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The guidance sets out the conditions under which the FDA generally does not intend to take regulatory action regarding stability testing and expiration date requirements. Read More
The agency said the conditions that created the need for the policy described in the document have evolved and the policy is no longer needed. Read More
Newly released federal guidance details how the federal government will punish drug companies that hike prices faster than the rate of inflation for some prescription Medicare medicines — a move some lawmakers view as long overdue. Read More
FDA Commissioner Robert Califf says the agency needs to improve how it makes use of advisory committees, likening them to artificial intelligence (AI) algorithms, which need constant input to function effectively. Read More
The FDA has issued two complete response letters (CRL) to Phathom Pharmaceuticals, one for a new drug application (NDA) for its acid suppressant vonoprazan for treating erosive esophagitis and another for a postapproval supplement for Voquezna, a combination therapy previously approved for treating Helicobacter pylori infections. Read More
The FDA highlighted the need for long-term neurodevelopmental studies by sponsors of neonatal medical products — whether a drug, biologic product or device — in a new draft guidance released Friday. Read More
The FDA has updated its guidance on the compounding of ibuprofen oral suspension products to include state-licensed pharmacies and federal facilities. Read More
FDA Commissioner Robert Califf responded to questions from members of the House Energy and Commerce Committee this week about the agency’s response to the COVID-19 pandemic, including their concerns about the agency’s ability to oversee the pharmaceutical supply chain. Read More