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The FDA added six bulk substances to its list of substances approved for use by compounding facilities exempt from certain FDA oversight activities under section 503A of the Food, Drug and Cosmetic Act. Read More
The FDA released final guidance outlining the expedited pathways available to sponsors of regenerative medicine therapies — including considerations for clinical trial designs for treatments of rare diseases. Read More
FDA Commissioner Scott Gottlieb on Friday announced the release of draft guidance on a new approval pathway for generic drugs and said the agency will roll out new policies over the next year aimed at increasing access to generics and boosting price competition for branded drugs. Read More
In most cases, Pfizer said, the total content for a drug, including drug substance overfill, isn’t known because the amount of overfill is not normally posted in the USPI or other sources of public information. Read More
The defendants allegedly filled prescriptions for controlled substances outside of the course of professional practice and did not properly ensure that they were written for legitimate medical purposes. Read More
Regulators on both sides of the Atlantic are optimistic they’ll meet the deadline, which they hope will allow them to direct more inspection resources elsewhere. Read More
A bipartisan appropriations bill for fiscal 2019 that would give the FDA $269 million more than in fiscal 2018 passed in the Senate and House on Thursday and is expected to be signed into law by the president. Read More
Members of the House Energy and Commerce Committee sent a letter to FDA Commissioner Scott Gottlieb on Wednesday calling for a briefing on the ongoing recalls of sartan blood pressure drugs and on the agency’s foreign inspections. Read More