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FDA’s decision on a widely watched follow-on biologics application should be delayed 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after the agency holds a meeting next month on the scientific issues related to follow-on biologics and develops a draft guidance next year on how to approve versions of the complex proteins, according to Pfizer.
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 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 FDA is in the early stages of developing a new guidance on how a genetic testing device could be co-developed with a drug or biologic to create a new combination product.
Senate Finance Committee Chairman Chuck Grassley (R-Iowa) is urging drug companies to educate their employees about provisions of the False Claims Act (FCA).
The FDA plans to implement a series of recommendations during the next half year on best management practices relating to the agency’s drug review process.
In a guidance issued last week, the FDA said that in regulations and policy statements where the term "available therapy" is not defined, the phrase should be interpreted as therapy that is specified in the approved labeling of regulated products, with only rare exceptions.