Review Pathways
The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.
In another surprise leadership move, Commissioner Martin Makary named Høeg, who has stirred controversy with her involvement in FDA vaccine issues, the interim replacement for Richard Pazdur.
With the roll out of agentic AI, the US FDA continues to expand its capabilities, following the launch of Elsa, its generative AI tool in May.
The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.
India is advancing regulatory rationalization efforts, refining procedures and pathways. Guidelines for biosimilars are expected to align with international standards, while early steps towards PIC/S compliance have been initiated.
ANDA sponsors received 20 days to pay fees associated with applications submitted during the government shutdown, while NDA and BLA sponsors only received five days.
The FDA proposed changes to the formal meeting system for sponsors in the next generic drug user fee program cycle, in part to speed timelines.
During the first GDUFA IV negotiation session, industry representatives were unsure whether the FDA’s idea to create pathways for onshoring incentives fit the scope of the generic drug user fee program.
A new reliance pathway under which regulators will rely on each other’s assessment reports strengthens the goals of key continental health initiatives, including the newly formed African Medicines Agency.
Denecimig, Novo Nordisk’s prophylaxis treatment for hemophilia A, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.
Concept outlined in NEJM by current FDA leaders is a ‘reasonable’ mechanistic approach that had been in development for several years, former Center for Biologics Evaluation and Research Director Peter Marks said.
A new service from the European Medicines Agency offers developers of products targeting public health emergencies combined regulatory advice on marketing authorization and clinical trials.
The US FDA’s Oncology Center of Excellence is eager to work with osteosarcoma researchers to advance trials for the difficult to study cancer – but OCE officials made clear that they are not likely to use mandatory pediatric study authorities to force the issue.
A cluster of CRLs for rare disease applications based on one trial plus confirmatory evidence may represent a shift away from the regulatory flexibility that had come to characterize ultra-rare drug development
The UK’s early access to medicines scheme could be due a rethink, a senior figure from the Medicines and Healthcare products Regulatory Agency has suggested, after feedback indicated “discontent” with how the program functions.
Five of the six winners of the US FDA’s second batch of Commissioner’s National Priority Vouchers are for secondary indications. That is no accident, Commissioner Makary says.
The UK Medicines and Healthcare products Regulatory Agency said its RegulatoryConnect program “no longer offers value for money for UK taxpayers” and will be closed just 19 months after its April 2024 launch.
Elevating the Office of Therapeutic Biologics and Biosimilars out of the Office of New Drugs and providing signatory authority could help speed biosimilar reviews, OTBB Director Sarah Yim said.
Manufacturers who succeed in treating several patients with bespoke therapies could leverage platform data to gain marketing approval for similar products in additional conditions, FDA leaders say in a NEJM article that describes five prerequisites for use of the new pathway.
A senior AstraZeneca executive says the UK MHRA must develop specialist expertise and create incentives for companies to file marketing authorizations nationally if it wants to stand out to strategic decision-makers.