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The FDA has received 150 inquiries from generic companies that have had trouble accessing samples, CDER Director Janet Woodcock told lawmakers at a House oversight subcommittee hearing. Read More
The FDA officially unveiled its recommendations for the second generation of user fee agreements covering generics and biosimilars, with commitments to eight-month reviews of priority generics. Read More
Democrats grilled industry representatives on drug pricing Tuesday at a Senate health committee hearing on reauthorizing the FDA’s user fee programs. Read More
India’s top drug regulatory body plans to fast-track approvals for combination products recommended by the World Health Organization to treat HIV and hepatitis B and C. Read More
Republican leaders from the House Energy and Commerce Committee have asked the FDA to provide all documents related to the agency’s criminal investigations into the heparin contamination crisis. Read More