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The FDA released a straight-to-final guidance on steps drugmakers should take to prevent high levels of nitrosamine impurities in their products. Read More
Drugs and biologics may fit into one of four categories when it comes to their use in patients age 65 and up, the FDA says in a new draft guidance on geriatric information for prescription product labeling. Read More
Jack Garvey, founder and CEO of Compliance Architects, a firm specializing in GMP, quality and compliance services, calls for caution in applying the FDA’s new compliant-manufacturing resumption guidance.Read More
In a proposed rule, the FDA clarifies how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
The FDA is urging drugmakers to develop a “resumption plan” to help them prioritize as they get back to normal operations and resume current good manufacturing practice (CGMP) activities that were modified or delayed due to COVID-19. Read More
New guidance from the FDA that would set tougher conditions for COVID-19 vaccine Emergency Use Authorizations (EUAs) remains under White House review, and it is unclear when — or if — it may be released. Read More
Gilead Sciences has resumed direct distribution to hospitals of its antiviral drug remdesivir, after HHS decided that the federal government no longer has to control the process because there is a sufficient supply to treat COVID-19 patients. Read More
Pending FDA approval or authorization, the HHS Secretary said Friday he anticipates having enough vaccine manufactured by the end of 2020 to vaccinate certain priority populations and enough to vaccinate all Americans by March to April 2021. Read More
Catalyst Pharmaceuticals saw its lawsuit against the FDA and competitor Jacobus Pharmaceutical dismissed this week by a federal court in Florida. Read More