FDA on Sept. 1 issued a final rule that requires firms to electronically submit drug registration information and clarifies who must register their establishments. The final rule goes into effect on Nov. 30, more than 10 years first proposed.
FDA has made “significant changes” to its drug registration and listing requirements in a final rule published on Sept. 1.
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Aragen’s CEO Manni Kantipudi, who is keenly watching the Trump Administration’s moves on pharma tariffs, discusses funding cuts at the National Institutes of Health, big pharma’s US onshoring moves, and talks with the Indian government to solve intellectual property challenges in an interview.
Alonza Cruse, director of the Office of Human and Animal Drugs Inspectorate, and two other senior inspection officials are departing, along with Mark Raza, chief counsel from 2021 until January.
Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.
The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
The International Council for Harmonisation has consolidated and modernized its existing stability guidelines into one document, and addressed modern stability testing approaches like modeling, bracketing, and matrixing.
An investigation by the US Secretary of Commerce into pharmaceutical imports gives industry an opportunity to comment. AAM CEO John Murphy talked to Pink Sheet's sister publication Scrip about the latest developments.
Cellares’ fully automated cell therapy manufacturing platform is the first system to receive an Advanced Manufacturing Technology designation from US FDA
