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A guidance document released by the FDA instructs clinical
trial sponsors on when and how to request that the agency engage
an independent consultant to participate in reviewing clinical studies, which serve as the primary basis of efficacy claims.
Aventis Pharmaceuticals has revised its labeling of the drug Lovenox (enoxaparin sodium) to better inform physicians prescribing medications to patients suffering from renal impairment.
The FDA has disregarded its own precedent that authorized generics are functionally and legally equivalent to true generics by allowing a brand-authorized generic to launch during Mylan Pharmaceutical’s generic marketing exclusivity period, Mylan argued in a lawsuit.
The FDA’s Center for Biologics Evaluation and Research (CBER) has issued a warning letter to Novo Nordisk Pharmaceuticals for promotional materials that failed to include risk information and made misleading safety claims about its NovoSeven coagulant product.
The FDA has released a guidance document that instructs clinical trial sponsors on when and how to request that the agency engage an independent consultant to participate in reviewing clinical studies, which serve as the primary basis of efficacy claims.
The state of Illinois is about to introduce a prescription drug importation program that goes far beyond anything any other state or municipality has so far attempted.
The Centers for Medicare & Medicaid Services is restructuring its Center for Beneficiary Choices (CBC) in preparation for what it says is the biggest expansion of Medicare benefits in the history of the program.
The FDA will hold a two-day meeting, Sept. 14-15, to discuss scientific issues related to developing follow-on biologics and to examine what factors should be considered when assessing the similarities between a follow-on protein and the innovator product.
Pfizer wants the FDA to delay its decision on a widely watched follow-on biologics application until after the agency holds a meeting next month on the scientific issues related to follow-on biologics and develops a draft guidance next year on how to approve versions of the complex proteins.
Genentech has updated the labeling and package inserts for its Avastin anticancer drug to include additional warnings about cardiovascular risks associated with the use of the drug.