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Manufacturers may obtain marketing authorization based on less-than-comprehensive applications if they supplement their filings with clinical data. Read More
Excipient makers preparing for the new GMP standard NSF/IPEC/ANSI 363 should be aware they are expected to police themselves to determine if they are meeting manufacturing requirements for their products. Read More
The FDA’s Oncologic Drugs Advisory Committee largely appeared to agree that Eli Lilly’s lung cancer drug necitumumab offers some late-stage lung cancer patients increased survival time, despite an increased risk of adverse events, but didn’t vote on whether to recommend the product for approval. Read More
The European Medicines Agency has issued draft guidance on the manufacture of finished dosage forms, clarifying what information drugmakers should include in the quality section of the common technical document that is part of a premarket application. Read More
The South Carolina Supreme Court slashed nearly $12 million from the penalty imposed against Johnson & Johnson’s Janssen subsidiary for allegedly hiding risks associated with the antipsychotic Risperdal. Read More
After considering a slew of proposed amendments to the 21st Century Cures Act, the House Rules Committee agreed on only one that affects drugmakers: a provision requiring the Centers for Disease Control and Prevention to conduct a study to determine how additional Medicare payments for new antimicrobial drugs are affecting the development of drug resistance. Read More
CDER plans to spread drug company inspections across three of its offices — the Office of Regulatory Affairs, Office of Pharmaceutical Quality and Office of Compliance — rather than conduct all inspections through OPQ, center officials said Wednesday. Read More
The second former Gallant Pharma International employee in as many days has been barred by the FDA from doing business in the U.S., after she was convicted of a felony for selling counterfeit drugs. Read More