Advisory Committees

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 13 May 2013 00:00:11 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Merck Comes Prepared This Time As Sugammadex Faces Second Advisory Committee

Fri, 10 May 2013 15:35:00 -0400

After failing to submit safety data on time during the drug’s first FDA review, Merck has its data together and is armed with a new hypersensitivity study in advance of the second panel review for its anesthesia product.

Endo’s Aveed and the State of REMS After Five Years

Tue, 07 May 2013 15:00:00 -0400

The REMS era is five years old – almost as old as the original NDA filing for Endo’s long-acting testosterone injection Aveed. A recent FDA advisory committee review of that application (now on its third cycle) captures many of the current themes in REMS policy.

FDA Risk Communication Panel Critiques MedWatch, And MedWatcher App

Mon, 06 May 2013 00:01:44 -0400

Promotion of the consumer MedWatch form and the newly released MedWatcher adverse event reporting app needs to be improved if more physicians and consumers are to use it, FDA’s Risk Communication Advisory Committee says.

Tivozanib Survival Data Go Wrong Way With One-Way Crossover Design

Mon, 06 May 2013 00:00:33 -0400

Aveo’s decision to allow only patients on the pivotal trial’s comparator arm to cross over to subsequent targeted therapy was a design flaw that made it impossible to assess the true picture of tivozanib’s effect on overall survival, FDA advisory committee members said.

Aveo’s Tivozanib Troubles Reflect Perils Of Ex-U.S. Studies

Mon, 06 May 2013 00:00:32 -0400

Pivotal study for the renal cell carcinoma drug was conducted largely in Central and Eastern Europe, where limited access to second-line targeted therapies does not reflect the U.S. practice. In recommending against approval, FDA’s Oncologic Drugs Advisory Committee questioned the study results’ applicability to the U.S.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 06 May 2013 00:00:14 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Astellas, Partner Aveo Rejected By U.S. FDA Panel For Kidney Cancer Drug

Fri, 03 May 2013 02:55:11 -0400

Astellas Pharma and its non-Asia development partner Aveo Pharmaceuticals received a no vote from a U.S. FDA advisory committee for the Japan drug maker's tivozanib for treating kidney cancer.

From Monkeys To Men: Panel Will Review Use Of Animal Rule For Filgrastim As Radiation Countermeasure

Fri, 03 May 2013 00:00:00 -0400

FDA’s Medical Imaging Drugs and Oncologic Drugs Advisory Committee will discuss whether evidence supports approval of filgrastim as a medical countermeasure for radiation-induced bone marrow injury using the “animal rule.”

Aveo’s Tivozanib Falls On Survival Data, Study Design Flaws

Thu, 02 May 2013 17:10:01 -0400

In a lopsided vote, FDA’s Oncologic Drugs Advisory Committee said the renal cell carcinoma drug has not been shown to have a favorable benefit/risk profile due to a negative trend in overall survival and flaws in the design and conduct of the sole pivotal trial.

FDA Risk Communications Panel Critiques MedWatch, And Medwatcher App

Thu, 02 May 2013 00:00:02 -0400

From Monkeys To Men: Panel Will Review Use Of Animal Rule For Filgrastim As Radiation Countermeasure

Wed, 01 May 2013 22:45:00 -0400

FDA Rejects Titan’s Probuphine Despite Positive Panel Vote

Wed, 01 May 2013 18:50:02 -0400

FDA’s “complete response” letter for abuse-resistant buprenorphine for opioid dependence follows an advisory committee that aired concerns about efficacy and adequate dosing, as well as questioning the proposed Risk Evaluation and Mitigation Strategy.

Clinical Benefit Of Hepatic Progression-Free Survival Confronts ODAC

Tue, 30 Apr 2013 18:10:00 -0400

A REMS may not be sufficient to address serious toxicity questions about Delcath Systems’ Melblez kit for resectable ocular melanoma that is metastatic to the liver, FDA says in briefing materials for the May 2 advisory committee review of the combination product.

Approval Or New Study? That’s The Question For Tivozanib Panel Review

Tue, 30 Apr 2013 16:00:00 -0400

FDA’s Oncologic Drugs Advisory Committee is being asked whether Aveo’s renal cell cancer drug should be approved despite an unfavorable overall survival trend in the sole pivotal study; Aveo attributes the survival results to the trial’s one-way crossover design and large proportion of patients from Central/Eastern Europe.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 29 Apr 2013 00:00:29 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

FDA Panel Discusses Extreme Weather’s Effect On Medical Device Availability

Mon, 22 Apr 2013 00:01:38 -0400

FDA’s Device Good Manufacturing Practice Advisory Committee met April 11 to help the agency develop better policies to prepare for and respond to extreme weather conditions that impact medical devices.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 22 Apr 2013 00:01:05 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Breo Ellipta Review Pits Clinical Benefits Against Statistical Shortcomings

Mon, 22 Apr 2013 00:00:54 -0400

FDA advisory committee majority favored approval of GlaxoSmithKline’s fluticasone furoate/vilanterol combination for COPD despite the failure, under a prespecified statistical analysis plan, to demonstrate significant results on all primary endpoints. GSK is developing the drug with Theravance.

ODAC Veterans Disagree On Value Of Public Hearing At Panel Meetings

Mon, 22 Apr 2013 00:00:23 -0400

Current and former chairs of FDA’s Oncologic Drugs Advisory Committee debate the usefulness of the public hearing and its impact on committee deliberations.

From Avastin To Zevalin: ODAC’s Most Memorable Moments

Mon, 22 Apr 2013 00:00:21 -0400

The current and former leaders of FDA’s Oncologic Drugs Advisory Committee recount their most memorable moments of service on the panel.

GSK’s Breo Ellipta Gains FDA Panel Nod For Airflow Obstruction, Exacerbation Claims

Wed, 17 Apr 2013 22:20:01 -0400

FDA’s Pulmonary-Allergy Drugs Advisory Committee recommended approval of the once-daily product for chronic obstructive pulmonary disease despite questions about the relative contribution of the combination drug’s corticosteroid component.

Endo’s Testosterone REMS, Revised Dosing Don’t Solve FDA Concerns

Tue, 16 Apr 2013 23:50:00 -0400

FDA briefing documents for the advisory committee review of Endo’s Aveed cite the “excessive burden” imposed by any one of the REMS restrictive elements, given the injectable testosterone’s limited additional benefit compared to other available treatment options.

2013 FDA Advisory Committee Recommendations

Tue, 16 Apr 2013 16:05:19 -0400

Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 15 Apr 2013 00:00:03 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

CMS Will Weigh Three New Tech Assessments On Genetic Testing For Cancer

Mon, 08 Apr 2013 15:40:01 -0400

Two of the assessments are intended to inform an upcoming Medicare Evidence Development and Coverage Advisory Committee meeting.

CMS Will Weigh Three New Tech Assessments On Genetic Testing For Cancer

Mon, 08 Apr 2013 00:01:36 -0400

Two of the assessments are intended to inform an upcoming Medicare Evidence Development and Coverage Advisory Committee meeting.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 08 Apr 2013 00:00:11 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Merck’s Suvorexant To Face FDA Panel Scrutiny On Next-Day Driving Effects

Wed, 03 Apr 2013 17:05:00 -0400

The Peripheral and Central Nervous System Drugs Advisory Committee’s May 22 review of the first-in-class insomnia drug will include data from two studies assessing the compound’s residual effects on next-day driving.

Titan’s Probuphine May Be Limited By Implant Procedure

Mon, 01 Apr 2013 00:01:37 -0400

Extensive requirements for training and equipping non-surgical specialists to implant the product for opioid dependence treatment may scare some clinicians away from using it, advisory committee members say.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 01 Apr 2013 00:00:17 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

We Don’t Kick Diabetics Out for Eating Ice Cream: Issues With Efficacy in Addiction Therapy

Thu, 28 Mar 2013 00:00:00 -0400

An Advisory Committee review of Titan’s Probuphine highlights the difficulties of measuring addiction treatment products: how to quantify success when even opioid-positive urine samples can be a good sign.

FDA Plants OB-GYNs on Implant Addiction Therapy Committee; Titan Harvests Yes Vote

Wed, 27 Mar 2013 14:30:00 -0400

An advisory committee reviewing Titan’s Probuphine for abuse dependence leaned heavily on reassuring safety perspectives of two guest members invited for their particular expertise. No, they weren’t addiction experts.

In Brief

Mon, 25 Mar 2013 00:01:00 -0400

Perrigo ships generic Mucinex extended-release; Valeant buys Obagi Medical Products; FDA advisory committee will discuss AERs; DXM legislation offered again; bill revived to allow Primatene Mist sales; Intercore will market MeliaLife products; more news In Brief.

FDA Neonatology Strategic Plan Should Focus On Commonly Used NICU Drugs

Mon, 25 Mar 2013 00:00:47 -0400

In its first meeting, the neonatology subcommittee of FDA’s Pediatric Advisory Committee discusses challenges to studying therapeutics in infants during their first month of life and strategies for getting more neonatal-specific information about commonly used drugs into labeling.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 25 Mar 2013 00:00:31 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Titan’s Probuphine Gets Panel Endorsement, But With Many Caveats

Thu, 21 Mar 2013 23:15:00 -0400

FDA’s Psychopharmacologic Drugs Advisory Committee outlines multiple concerns with the implantable opioid dependence product, including REMS problems and a lack of sufficient dose-ranging studies.

FDA Questions Efficacy Of Titan’s Probuphine Ahead Of Advisory Committee

Tue, 19 Mar 2013 17:35:00 -0400

Some patients still need a prescription for supplemental sublingual tablets, FDA says, which may take away the continuous-release implant’s advantage for treating opioid dependence.

2013 FDA Advisory Committee Recommendations

Tue, 19 Mar 2013 15:40:02 -0400

Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions.

Salmon Calcitonin and the Challenge of Life-Cycle Regulation

Mon, 18 Mar 2013 16:45:00 -0400

An advisory committee is recommending pulling the osteoporosis indication for salmon calcitonin. The product is, to put it bluntly, outdated: approved on standards FDA no longer accepts and now commericially irrelevant.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 18 Mar 2013 00:00:06 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

FDA Advisory Committees Could Become Teleconferences Due To Sequestration

Fri, 15 Mar 2013 19:05:00 -0400

Oncology Drugs Advisory Committee Chairman Mikkael Sekeres says meetings without gathering panel members in one place would make his job “challenging … but not impossible.”

FDA’s New Neonatology Panel To Discuss Challenges In Study Design, Conduct

Thu, 14 Mar 2013 00:00:01 -0400

Discussion by the Pediatric Advisory Committee’s new subcommittee at a March 15 meeting will aid the agency’s development of a strategic plan for advancing neonatal science; FDA also is looking to outside contractors for help in meeting a FDASIA mandate to bolster neonatology expertise and encourage studies.

FDA’s New Neonatology Panel To Discuss Challenges In Study Design, Conduct

Tue, 12 Mar 2013 18:44:51 -0400

Serotonin Syndrome Concerns Could Be Added To Anti-emetics’ Labeling

Mon, 11 Mar 2013 23:20:05 -0400

CDER safety staff will present the case for adding labeling about the condition during a March 14 Pediatric Advisory Committee review of pediatric adverse events for 16 drugs, including Hoffman-LaRoche’s Kytril, a member of the 5-HT3 receptor antagonist class.

Placebo Effect Raises Questions About Clinical Value For Depomed, Noven Hot Flash Treatments

Mon, 11 Mar 2013 00:00:50 -0400

Advisory Committee for Reproductive Health Drugs asks whether FDA standards are too difficult to meet for non-hormonal products like gabapentin and paroxetine after the placebo arms of both drugs’ trials show a strong reduction in vasomotor symptoms.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 11 Mar 2013 00:00:07 -0400

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

METI Sets New Plan For Use Of Microbial Genetic Resources In Drug Discovery

Fri, 08 Mar 2013 01:10:07 -0500

The Japanese Ministry of Economy, Trade and Industry presented its new development plan regarding microbial genetic resources used for drug development to their advisory committee on Feb. 28.

Delcath’s Melblez Chemosaturation System To Face ODAC Scrutiny

Thu, 07 Mar 2013 15:20:01 -0500

FDA’s Oncologic Drugs Advisory Committee will review the drug/device combination for treatment of patients with unresectable ocular melanoma that is metastatic to the liver. The system, which uses the chemotherapy drug melphalan, has shown significant improvement in hepatic progression-free survival.

GSK’s Breo Ellipta Gets “Snowquestered” As FDA Delays Advisory Cmte

Tue, 05 Mar 2013 23:30:02 -0500

FDA missed its deadline to post the advisory committee briefing materials then postponed the meeting as a winter storm headed towards Washington.

Gabapentin Cannot Navigate Efficacy Hurdles At Advisory Committee

Mon, 04 Mar 2013 21:05:02 -0500

FDA Advisory Committee on Reproductive Health Drugs votes overwhelmingly against recommending approval of new indication for severe to moderate vasomotor symptoms, saying the modest effect shown was not sufficient.

Prevnar 13 Gets Expansive Recommendation On Children From ACIP

Mon, 04 Mar 2013 00:02:37 -0500

CDC’s Advisory Committee on Immunization Practices recommends the vaccine for immunocompromised children 6 through 18 even if they’ve already received the previous version of Prevnar or Merck’s product; ACIP also votes to include GlaxoSmithKline’s MenHibrix in the Vaccines for Children program.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 04 Mar 2013 00:00:11 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

“Hot Flash” Persistence At Week 12 Suggests Cool Reception For Products At FDA Cmte

Thu, 28 Feb 2013 22:00:01 -0500

Advisory Committee for Reproductive Health Drugs will consider efficacy of Depomed’s and Noven Therapeutics’ vasomotor symptom treatments, but both had problems maintaining their effects at week 12 of clinical trials.

Probuphine Panel Review Could Be A Test Of Titan’s Delivery Technology

Thu, 28 Feb 2013 20:40:01 -0500

FDA will convene an advisory committee review of the buprenorphine implant for opioid dependence – an established use for the drug, but the first in an extended-release delivery system.

Aveo’s Tivozanib Will Face Challenging Survival Data At ODAC Review

Tue, 26 Feb 2013 17:30:01 -0500

FDA’s Oncologic Drugs Advisory Committee will consider the tyrosine kinase inhibitor for advanced renal cell carcinoma at a May 2 meeting. Aveo has attributed a negative overall survival trend in the TIVO-1 study to a crossover design and use of post-progression therapies among patients randomized to the comparator arm.

FDA Examines Extreme Weather Impact On Device Supply Chains

Mon, 25 Feb 2013 00:00:18 -0500

The agency called an advisory committee meeting and public comment period to collect feedback from device firms and others on effects that extreme weather and natural disasters pose to medical device safety and quality.

Flu Vaccines Likely To Remain Immune From Comparative Effectiveness

Mon, 25 Feb 2013 00:00:10 -0500

CDC’s Advisory Committee on Immunization Practices adds four recently-approved flu vaccines to its recommended list of products, but the committee chair expresses doubt that there could ever be data to make preferential recommendations.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 25 Feb 2013 00:00:06 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Flu Vaccines Likely To Remain Immune From Comparative Effectiveness

Thu, 21 Feb 2013 21:30:01 -0500

2013 FDA Advisory Committee Recommendations

Wed, 20 Feb 2013 11:40:06 -0500

Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions.

Senator Manchin Goes to White Oak

Wed, 20 Feb 2013 00:00:00 -0500

The open public hearing portion of an advisory committee is often emotional and sometimes persuasive. It is not usually a forum for a give-and-take with a sitting US Senator.

FDA Panel Rejects Guerbet’s Imaging Drug Dotarem For Young Children

Tue, 19 Feb 2013 00:00:01 -0500

The gadolinium-based contrast agent should be approved for use in adults and older pediatric patients, but more data are needed to support a novel indication for children under two years old, the Medical Imaging Drugs Advisory Committee says.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 18 Feb 2013 00:00:05 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

FDA Panel Rejects Guerbet’s Imaging Drug Dotarem For Young Children

Thu, 14 Feb 2013 21:10:02 -0500

Pediatric Claim For Guerbet’s Imaging Agent Dotarem Questioned By FDA

Tue, 12 Feb 2013 16:15:01 -0500

In advisory committee briefing documents, agency reviewers cite limitations in gadoterate’s pediatric experience, particularly among patients two years of age and younger. This is the key population that would differentiate Dotarem from other gadolinium-based contrast agents already on the market.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 11 Feb 2013 00:00:16 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

How Not To Develop A Drug

Wed, 06 Feb 2013 16:20:00 -0500

What is the best way to encourage drug development in an unmet medical need? Chronic Fatigue Syndrome advocates argue that FDA should approve a drug—specifically Ampligen—even if it falls far short of reaching typical standards of evidence.

Bronchitol AdComm Shows Difficulty Of Following In Kalydeco’s Shadow

Mon, 04 Feb 2013 00:01:40 -0500

Comparisons between the robustness of the efficacy data for dry powder mannitol and Vertex’s ivacaftor were difficult for FDA to avoid during the Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 review of Pharmaxis’ cystic fibrosis drug.

Hydrocodone Up-scheduling: FDA Faces Philosophical Toss-Up After Advisory Cmte.

Mon, 04 Feb 2013 00:01:36 -0500

Two-thirds of FDA’s Drug Safety and Risk Management Advisory Committee say the combination products have a similar abuse profile as drugs already on Schedule II, but others note there is no guarantee drug abuse will decline with reclassification, which will adversely affect pain patients’ access to the drugs.

Boehringer’s Novel Exercise Claims In COPD May Spur FDA Action To Clarify Requirements

Mon, 04 Feb 2013 00:00:49 -0500

Company was hoping for an exercise tolerability claim for olodaterol, but members of the Pulmonary-Allergy Drugs Advisory Committee questioned several aspects of the trials and suggested FDA issue guidance on the matter.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 04 Feb 2013 00:00:38 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Pharmaxis’ CF Drug Bronchitol Gets Thumbs Down From FDA Panel

Fri, 01 Feb 2013 00:00:01 -0500

Advisory committee members said pediatric efficacy and safety concerns precluded approval of dry powder mannitol for the broad indication of improving pulmonary function in cystic fibrosis patients ages six years and older.

Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch

Thu, 31 Jan 2013 14:00:00 -0500

FDA approved Merck’s overactive bladder drug Oxytrol for Women for OTC use, despite concerns raised by the Nonprescription Drug Advisory Committee in November. The company plans a launch in the fall.

Pharmaxis’ CF Drug Bronchitol Gets Thumbs Down From FDA Panel

Wed, 30 Jan 2013 20:45:01 -0500

Boehringer’s Olodaterol Gains Advisory Committee Support, But May See Indication Clarified

Tue, 29 Jan 2013 19:25:01 -0500

FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 15-1 that efficacy and safety had been shown, but said the label should not imply it is a treatment for chronic bronchitis and emphysema, just airway obstruction in those conditions, as well as COPD.

Pharmaxis’ Bronchitol Will Face Efficacy Questions At FDA Panel Review

Mon, 28 Jan 2013 17:00:01 -0500

Several statistical issues, including differential rates of missing data between treatment arms in the pivotal studies, make it difficult to assess mannitol’s benefit in cystic fibrosis patients, FDA says in briefing documents for the Pulmonary-Allergy Drugs Advisory Committee’s Jan. 30 meeting.

Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch

Mon, 28 Jan 2013 00:01:17 -0500

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 28 Jan 2013 00:00:44 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Hydrocodone Combination Up-scheduling Marches Forward Despite FDA Ambivalence

Fri, 25 Jan 2013 22:20:00 -0500

FDA’s Drug Safety and Risk Management Advisory Committee votes 19-10 to move the opioid drugs to the more restrictive Schedule II because their abuse potential is similar to other drugs already that already have the controlled substances designation.

Oxytrol For Women Gets OTC Green Light As Rare First-In-Class Switch

Fri, 25 Jan 2013 12:05:01 -0500

Despite concerns raised by the Nonprescription Drug Advisory Committee in November, FDA approves Merck’s overactive bladder drug Oxytrol for Women for OTC use. The company plans a launch in the fall.

2012 FDA Advisory Committee Recommendations

Wed, 23 Jan 2013 13:00:05 -0500

Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions.

2013 FDA Advisory Committee Recommendations

Wed, 23 Jan 2013 12:55:00 -0500

Year-to-date tracking of drug review recommendations from FDA advisory panels, including regulatory actions.

Use Of Pre-Approval CV Data From Ongoing Trial Gets Once-Over At Canagliflozin Panel

Mon, 21 Jan 2013 00:00:39 -0500

There is no statistical reason not to allow a single trial to provide pre-approval and post-approval cardiovascular hazard ratios for a diabetes drug, FDA says, but Janssen’s canagliflozin would be the first. The Endocrinologic and Metabolic Drugs Advisory Committee backed approval 10-5.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 21 Jan 2013 00:00:08 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

In With The Old? 2013 To Mark Rebirth Of CDER’s Pharmacy Compounding, Medical Imaging AdComms

Mon, 14 Jan 2013 00:01:00 -0500

FDA has signaled that it will re-form its Pharmacy Compounding Drugs Advisory Committee, which was dissolved in 2002, as it deals with an ongoing meningitis outbreak related to compounded steroid injections. 2012 proved to be another busy year for the Oncologic Drugs Advisory Committee, but the full drug safety/risk management panel saw a significantly lighter workload than in recent years.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 14 Jan 2013 00:00:26 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Contraceptive Data Repository For Teratogenic Drug Patients Urged By FDA Panel

Mon, 14 Jan 2013 00:00:04 -0500

An updatable web-based repository of information on contraceptives would remedy the shortcomings of the current system, where information differs across drugs and is only as current as labeling, several members of the Drug Safety and Risk Management Advisory Committee note during a meeting on teratogenic risk management.

Teratogenic Drugs Pose Little Risk To Partners Of Male Patients, FDA Panel Says

Mon, 14 Jan 2013 00:00:02 -0500

There is little to no evidence that a teratogenic drug would pass from a man to his female partner at a high enough level to endanger a fetus, the Drug Safety and Risk Management Advisory Committee tells FDA.

2012 FDA Advisory Committee Recommendations

Mon, 14 Jan 2013 00:00:00 -0500

Drug review recommendations from FDA advisory panels, plus regulatory actions, in 2012.

Canagliflozin Should Have Limitations Based On Renal Function, Panel Says

Thu, 10 Jan 2013 20:35:01 -0500

Several advisory committee members on both sides of a 10-5 vote voiced concern about using Janssen’s diabetes drug in patients with moderate renal impairment.

Cardiovascular Uncertainty Accompanies Canagliflozin To Advisory Panel

Tue, 08 Jan 2013 18:00:01 -0500

Janssen’s diabetes therapy also will undergo discussions about renal and bone fracture risks during a Jan. 10 meeting of FDA’s Endocrinologic and Metabolic Drugs Advisory Committee.

FDA Uses AdComm Process To Shine Light On Ampligen’s Troubled Development

Mon, 07 Jan 2013 00:00:28 -0500

December’s Arthritis Advisory Committee review of Hemispherx’s drug provided FDA with the first public opportunity to explain in detail why the chronic fatigue syndrome drug, in development for almost 25 years, has not passed regulatory muster to date.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 07 Jan 2013 00:00:04 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

FDA’s Advisory Committee Schedule Hints At Re-formulated Compounding Panel

Fri, 04 Jan 2013 16:30:01 -0500

The agency has not set a meeting date for the Pharmacy Compounding Drugs Advisory Committee, defunct since 2002, in its tentative schedule, but has included 13 vacancies on the panel in its list of committees in need of new members.

First Non-Hormonal Hot Flash Drugs Could Clear FDA Panel In March

Thu, 03 Jan 2013 17:55:06 -0500

Depomed’s gabapentin and Noven Pharmaceuticals’ paroxetine to get advisory committee review for a menopausal hot flash indication; while Phase III data for both drugs are positive, certain endpoints did not reach statistical significance in at least one study.

Guerbet Looks To Separate Dotarem In Crowded Contrast Agent Market

Thu, 03 Jan 2013 16:00:01 -0500

FDA advisory committee scheduled for Valentine’s Day is key test for Guerbet’s efforts to get its MRI imaging agent a wider indication than Bayer’s Gadavist.

Recent And Upcoming FDA Advisory Committee Meetings

Mon, 24 Dec 2012 00:00:04 -0500

Recent and upcoming FDA advisory committee meetings and a summary of topics covered.

Hemispherx’s Ampligen Needs Another Study, FDA Panel Says

Thu, 20 Dec 2012 21:00:00 -0500

Arthritis Advisory Committee recommends against approval of rintatolimod for chronic fatigue syndrome, saying that signs of efficacy seen in post-hoc analyses warrant further, prospective exploration in a new study before approval.

FDA Takes Dim View Of Ampligen For Chronic Fatigue Syndrome

Tue, 18 Dec 2012 16:25:01 -0500

In review documents released ahead of a Dec. 20 advisory committee meeting, agency questions the validity of Hemispherx’s post-hoc efficacy analyses and raises concerns about adverse events and the reliability of the safety data.