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The number of adverse events reported to the FDA’s Center for Drug Evaluation and Research (CDER) increased 15 percent last year largely due to electronic filing of adverse event reports, according to the center’s chief.
The FDA yesterday announced the availability of the most recent cumulative list of orphan drug and biological designations as of Dec. 31, 2003. The list includes the name of the drug or biological, the condition/disease for which the drug or biological is indicated and contact information for product sponsors.
The FTC has signed off on a deal between Bristol-Myers Squibb (BMS) and Teva Pharmaceutical that will give Teva nearly a four-month jump on launching a generic version of BMS’ cancer drug Paraplatin.
A California drugmaker and a New York dietary supplement manufacturer have been issued warning letters for a print promotion and product claims that violate the Federal Food, Drug and Cosmetic Act.
Citing past lapses in the rules governing drug testing samples, the FDA has issued a final guidance on how drugmakers and others should handle reserve testing samples used in bioavailabilty (BA) and bioequivalence (BE) studies that support new and generic drug applications.
HHS has established a public docket for input on how the department and its operating agencies -- including the FDA, the National Institutes of Health and the Centers for Medicare & Medicaid Services (CMS) -- can expedite the development and approval of new drugs and biologicals.
Generic-drug industry observers see mixed opportunities in Bristol-Myers Squibb’s (BMS’) recent decision to stop marketing its antidepressant Serzone (nefazodone HCl) — a decision that will give generics 100 percent market share of a former top-selling product now facing safety concerns.
A bill introduced by a bipartisan group of powerful Washington lawmakers that would require the FDA to regulate tobacco products has drawn support from an unlikely quarter — the holding company for one of the country’s largest tobacco companies.