The FDA released two draft guidances for biosimilar manufacturers — one on labeling that focuses on prescribing information and the other on the FDA’s licensure requirements. Source: Drug Industry Daily

To combat allegations of political interference — which may have impacted HHS’ response to the COVID-19 pandemic — HHS agencies, including the FDA, are updating their scientific integrity policies and…

In the latest in an ongoing dispute, CDER has strongly rejected Oncopeptides’ appeal of the agency’s attempt to request the drugmaker withdraw its multiple myeloma therapy Pepaxto (melphalan flufenamide). Source:…

Over the past week, the FDA issued final guidance on IRB review of individual patient expanded access submissions, postmarketing requirements and commitments, the Breakthrough Devices Program and the medical device…

The FDA’s work with cancer drug manufacturers has brought the cisplatin supply back to nearly 100 percent of the pre-shortage levels, the White House said in an announcement on Tuesday.…

On Thursday, the FTC voted unanimously (3-0) to issue a policy statement warning pharmaceutical companies that they could face legal action for improperly listing patents in the FDA’s Orange Book…

This special edition of Quick Notes covers FDA issuance of final guidance for the Breakthrough Device Program, drug postmarketing requirements and commitments and the CDRH voluntary improvement program as well…

Expert witnesses discussed the precarious nature of the U.S. generics supply chain during a House subcommittee hearing Thursday, highlighting how unless reforms are made the country is at risk of…

New FDA drug approvals in August include the first ever oral pill to treat postpartum depression, treatments for two ultra-rare diseases and the first vaccine for use in pregnant women…

CDER is seeking comments on the development of its Quality Management Maturity (QMM) program, establishing a public docket to collect input from stakeholders who manufacture human drugs, including biologics. Source:…