FDA has announced a multifaceted effort to tackle the oversight of drug compounding facilities this year. On the to do list: setting the groundwork for establishing centers for excellence for outsourcing facilities; finalizing a guidance on identifying insanitary conditions at drug compounding facilities, and finalizing a memorandum of understanding targeting traditional compounders that distribute an “inordinate” amount of their compounded drugs across state lines.
The US FDA plans to issue final guidance this year describing examples of insanitary conditions at drug compounding pharmacies and outsourcing centers and wants to set the groundwork for establishing centers of excellence to bolster the quality of compounded drugs produced by outsourcing facilities.
These efforts are part of the agency’s Compounding Policies Priorities Plan announced April 3. In a joint statement, FDA Commissioner...
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.
