To encourage drug compounding pharmacies to register as 503B drug outsourcing facilities, FDA plans to propose assigning these pharmacies a lower risk category, thus subjecting them to less stringent GMP controls if they make limited volumes of drugs as part of a “2018 Compounding Policy Priorities Plan” announced by FDA Commissioner Scott Gottlieb.
The US FDA plans to issue guidance soon that aims to encourage traditional 503A pharmacies to register as 503B outsourcing facilities by according them a lower level of risk, and thus a lower level of GMP oversight. This is one element of a five-point plan announced by FDA Commissioner Scott Gottlieb to tighten its oversight of drug compounding pharmacies.
The November 2013 Drug Quality and Security Act gave FDA clearer authority to regulate drug compounding facilities. The legislation was...
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.
