Pathways & Standards

After voting to change the recommendation for a hepatitis B vaccine birth dose, the CDC Advisory Committee On Immunization Practices laid the groundwork for for changes to adjuvant policy.

The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.

The FDA proposed conditions for eliminating six-month animal studies in mAb development and gave examples when shorter-duration studies could be eliminated.

The soon-to-be former CDER director will return to the oncology office to complete his FDA tenure, the agency said.

The tilt toward approval extended beyond patients and advocates to clinicians, professional societies and industry.

FDA’s proposed easing of biosimilar pathways is a mixed blessing for CROs even as it, along with tariff threats and funding scarcity, has led to paused clinical studies. Parexel’s India head talks about keeping up with the regulation and other AI-led changes in this interview.

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.

Non-malignant hematology, respiratory and cardiometabolic candidates make up for an unusual lack of oncology products on the US FDA’s December user fee goal calendar.

The FDA wants to charge a yearly fee after an IND is filed for firms that do not conduct Phase I clinical studies in the US as part of its proposal to encourage more domestic development.

The FDA told the Pink Sheet an ANDA managed to be submitted during a period when no new ANDAs could be accepted.

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.