FDALegislativeWatch

FDA Legislative Watch Special Update

2008-10-20T16:18:00-04:00

October 20, 2008 FDA Legislative Watch Special Update: The FDALegislativeWatch.com blog has just gotten better! BioPharma Today takes over where FDALegislativeWatch leaves off, taking the regulatory and legislative coverage of FDALegislativeWatch and adding business strategy, dealmaking, startup news and much...

U.S. FDA Inspections in China

2008-10-03T11:17:54-04:00

In 2008, foreign manufacturing sites will exceed domestic ones for U.S. FDA-regulated products for the first time. China has more establishments manufacturing drugs offered for entry into the U.S. than any other country. However, only 11 percent, or 80 of...

Digital Mammography Firms Decry Clinical Trial Provisions In Draft Guidance

2008-09-10T10:59:53-04:00

Digital mammography systems are on the verge of being downclassified to 510(k) status, but imaging firms say the clinical trial requirements proposed in FDA's draft "special controls" guidance for the systems are costly, unnecessary and overly burdensome. Full-field digital mammography...

Medicare Bundling Provisions Could Boost Affymax ESA in ESRD Arena

2008-09-10T10:58:45-04:00

Affymax sees the end-stage renal disease treatment bundling provisions in the Medicare Improvements for Patients and Providers Act as a potential opportunity for its new erythropoiesis stimulating agent to pull market share from Amgen's Epogen. "We expect these changes in...

FDA List Of Potential Safety Signals Has 3 Pfizer Drugs, Echoes Drug Watch Site

2008-09-10T10:57:07-04:00

FDA's quarterly report that lists potential signals of serious risks for drugs is similar in design to a program that the agency proposed and then withdrew following industry criticism. The new quarterly report, announced and posted on FDA's Web site...

Sweeping Changes In India’s Clinical Trial Laws Could Allow Phase I MNC Studies Under Certain Circumstances

2008-09-10T10:36:19-04:00

MUMBAI - Conducting clinical trials in India may get a little easier for multinational drug companies. That is because the much-awaited amendments to the contentious "Schedule Y" of India's Drug and Cosmetics Act have moved one step forward. Industry sources...

Physician Payment Disclosure Bill Should Include Other Entities – MedPAC

2008-09-10T09:56:28-04:00

The Medicare Payment Advisory Commission is recommending a more comprehensive system for reporting pharmaceutical industry payments than the one proposed in legislation pending before Congress. The Physician Payments Sunshine Act, first introduced in the Senate by Chuck Grassley, R-Iowa, and...

Pregnancy Registries Should Not Be Mandated In Drug Label, Amgen Tells FDA

2008-09-04T16:02:11-04:00

Industry is challenging one of the central components of FDA's proposed rule on pregnancy and lactation labeling - that any existing registries for patients should be included in labeling. From FDA's point of view, including information on pregnancy registries in...

Marketing Oversight By States Creates Multiple Compliance Standards For Firms

2008-09-04T15:58:27-04:00

As more and more states pass laws that require pharmaceutical companies to disclose payments to health care practitioners, there needs to be a single definition of which data must be reported, according to John Patrick Oroho, executive vice president of...

New Generics Need To Influence Medicare Rates More Quickly – OIG

2008-09-04T15:52:21-04:00

Health and Human Services' Office of Inspector General is calling on the Centers for Medicare and Medicaid Services to more quickly adjust reimbursement rates for Medicare Part B drugs when low-priced generics enter the market. In a report released August...