Comments cite requests for delayed or phased implementation, question how data will be used, and ask whether current reporting avenues could be used to gather similar information, among other concerns.
Draft guidance from the US Food and Drug Administration for implementing new statutory reporting requirements on pharmaceutical manufacturing activity drew a sharp response from industry by the 3 January comment closing date. Commenters were primarily concerned over the deadline the agency set, just weeks away, for filing initial reports.
The document, “Reporting Amount of Listed Drugs and Biological Products Under Section 510(j)(3) of the Food Drug & Cosmetic Act,”...
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Developments in India and Pakistan are designed to standardize how drug companies disclose their expenses associated with health care professionals.
The agency’s plan for advanced manufacturing seeks more harmonization, while also seeking to codify internal practices with guidance and training.
