FDALegislativeWatch

FDA Rejects “Not Approvable” Letters, Clarifies Efficacy Supplement

2008-07-15T11:36:16-04:00

FDA says industry concerns about the implied finality of "not approvable" letters led it to change how it responds to drug applications. Also in a 1final rule published in the July 10 Federal Register, FDA clarifies the definition of efficacy...

PhRMA’s Marketing Code Touts Sarbanes/Oxley-esque Compliance Mechanism

2008-07-15T11:21:41-04:00

The Pharmaceutical Research and Manufacturers of America's revised marketing code will use an executive certification standard similar to Sarbanes-Oxley to assure compliance. The new PhRMA rules were unveiled July 10 and take effect in January. The 1new code on company...

CMS Open To ASPs For Radiopharmaceuticals; Congress Blocks Rate Cap

2008-07-15T11:19:39-04:00

CMS is willing to consider switching Medicare Part B payment for radiopharmaceuticals to the average sales price formula, the agency says in proposed rules to update Medicare's hospital outpatient prospective payment system for 2009. The agency's expression of flexibility comes...

Manufacturers Negotiate With Japan For Higher User Fees To Speed Review

2008-07-15T11:17:21-04:00

By April 1 of next year the number of medical device reviewers in Japan could increase dramatically via a substantial raise in industry-paid user fees. "Intensive" negotiations to increase user fees and adopt changes that will speed Japan's approval process...

Congested OTC Monograph Process Can Leave Manufacturers Confused

2008-07-07T17:40:57-04:00

The disparity between FDA's OTC monographs and up-to-date communications from the agency can create confusion for manufacturers, Office of New Drugs Director John Jenkins acknowledges. At the Drug Information Association's conference in Boston June 26, Jenkins said the agency's consideration...

Pfizer CME Restrictions: No Support For Education Firms, Caps Everywhere Else

2008-07-07T17:29:20-04:00

In response to the medical community's call for continuing medical education to receive financing from a variety of sources, Pfizer is limiting the percentage of funding it will provide for any one CME program. Effective immediately, the firm also is...

FDA Learns By Doing In Using REMS Powers; Guidance In “Future”

2008-07-07T17:25:46-04:00

FDA decisions on whether to require a risk evaluation and mitigation strategy for a new drug will continue to be made on a case-by-case basis while the agency gains on-the-job experience in interpreting requirements of the FDA Amendments Act. There...

FY 2009 Approps Package Will Likely Need To Wait For Next Administration

2008-07-07T17:22:41-04:00

House Democratic leaders are signaling an intention to put off finalizing fiscal year 2009 appropriations at least until next March, charging Republican members of Congress and the Bush administration with standing in the way of negotiating mutually agreeable bills. The...

Behind-The-Counter Guidance Stalled, But Interest Grows To Expand Access

2008-07-01T12:36:58-04:00

FDA executives say behind-the-counter status for nonprescription drugs resonates in discussions at the agency, but a former deputy commissioner says the agency's BTC interests are stifled by not having explicit authority. Scott Gottlieb, a former FDA deputy commissioner for medical...

Device Pre-Market Review Times Dropped In ’06 and ’07

2008-07-01T12:34:05-04:00

FDA has been getting faster at reviewing device pre-market submissions during the past two years, according to the Office of Device Evaluation 2006-2007 annual report. In many cases, the reviews became quicker in terms of both the number of days...