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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. Read More
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 implementing new safeguards to protect against such interference, says a new report from the Government Accountability Office (GAO) issued Thursday. Read More
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). Read More
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 in an attempt to stave off competition. Read More
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 as draft guidances on clinical study design and non-clinical testing of weight loss devices. Read More
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 decreased access to key medications including chemotherapy drugs. Read More
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. Read More
Our coverage spans relief from third party funded mass tort litigation sought by the medical device industry to Apple prevailing in Masimo patent appeal and two class I device recalls. Read More
HHS has petitioned a federal court to toss out a lawsuit from Merck challenging the constitutionality of the Inflation Reduction Act (IRA)’s ability to empower Medicare to negotiate select prices of costly drugs. Read More
The Anti-Terrorism Act (ATA) requires a much higher level of conscious and culpable participation than just selling Iraqi Health Ministry health supplies, AstraZeneca and five other drug and devices makers say in their reply to the accusation that the companies engaged in acts of terrorism. Read More