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The long-awaited interim final rule on drugmakers’ submissions of average sales price (ASP) data does little to flesh out the generalities of the Medicare Prescription Drug, Improvement and Modernization Act regarding how to calculate ASP.
The active ingredient in a depression drug marketed before 1962 is effective, rather than “probably effective,” said the FDA, which will use the brand product as a reference-listed drug to approve generic equivalents.
The FDA has referred Elan Pharmaceuticals’ Zonegran, GlaxoSmithKline’s (GSK) Wellbutrin and Zyban and GelTex Pharmaceuticals’ Renagel to the Foundation for the National Institutes of Health (NIH) for pediatric studies that potentially could lead to new labeling for relevant pediatric populations.
The FDA will release in August a multicenter analysis of current good manufacturing practices (cGMPs), according to acting FDA Commissioner Lester Crawford.
A potential precedent-setting ruling by the California Supreme Court upholding FDA warning labeling represents an important victory for the agency, GlaxoSmithKline and the industry at large.
The biotechnology industry has a tremendous hunger for more FDA guidance on how to navigate the drug approval process for biological products, according to an industry attorney.
Legal experts warned drugmakers last week not to "get ahead of the FDA" in making safety and efficacy claims about pipeline products in light of recent changes in the way the agency and the Securities and Exchange Commission (SEC) share confidential information about drug approval procedures.
After waiting three months for the FDA to respond to an Illinois pilot program to reimport drugs from Canada, Democratic Gov. Rod Blagojevich has asked the agency to implement a nationwide Canadian reimportation program — and threatened to sue if a response is not issued by October.
The FDA is publicly threatening to prosecute U.S. health plans that cover the cost of drugs bought by their members from foreign countries yet behind closed doors the agency is allegedly saying the opposite to insurers, according to a spokesman for Blue Cross and Blue Shield (BCBS) of North Dakota.