CDER director Janet Woodcock says the Covid-19 pandemic has led to a further deterioration in the U.S. clinical trials system.
Federal Register notice: FDA makes available a draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuti...
Federal Register notice: FDA makes available a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Ti...
Federal Register notice: FDA makes available a final guidance on Breast Implants Certain Labeling Recommendations to Improve Patient Communication.
FDA issues a draft guidance with questions and answers for two International Council for Harmonization guidances.
FDA awards a $5 million grant to two universities to create a Center for Research on Complex Generics.
The HHS Inspector General says REMS are not well suited to quickly address the opioid crisis and makes four recommendations to improve their use.
Former FDA principal deputy commissioner Joshua Sharfstein and two co-authors suggest four ways FDA could recommit to greater transparency in Covid-19...