Derrick Gingery

The guidance, intended to help sponsors meet bioequivalence requirements for generic drugs, replaces a draft issued in 2021.

The guidance finalizes a draft issued in December 2022 and replaces guidance issued in February 2001.

The FDA proposed a goal date for biosimilars that are approvable and waiting for exclusivity to run out, but industry said expiration dates often are unknown.

Pink Sheet editors discuss the federal government's proposed nondisclosure agreement for all employees and its impact on the FDA, as well as the impact of the agency's hiring push on user fee renewals.

The long-time FDA Oncology Center of Excellence director joins former FDA and NCI officials on the FOCR board of directors.

The executive order mandating the ACIP review a controversial scientific assessment of childhood vaccine recommendations suggests the committee could be ready to move beyond its legal troubles, which included a judge invalidating the appointment of most of its members.

The company and agency exchanged responses for weeks on new language warning patients could develop neutralizing antibodies for the enzyme replacement therapy before FDA instructed Takeda to make changes.

The Office of Management and Budget is reviewing a notice on an FDA expedited investigational new drug pilot program, an idea Martin Makary championed while FDA commissioner.

A reporter and editors from the Pink Sheet and Generics Bulletin discuss the future of generic drug skinny labels after a US Supreme Court decision saved the system, as well as the ongoing questions about the FDA’s National Priority Voucher program.

The meeting raises questions about whether political officials influenced the FDA to review the application a third time.