The US FDA’s revised draft MOU on interstate compounding, which stipulates new controls to ensure that pharmacies do not ship an “inordinate” amount of drugs across state lines, needs strong state oversight and robust information collection to work, say some groups commenting on the agreement. Yet two members of Congress are challenging the MOU on the grounds that some states and state boards of pharmacy lack the regulatory authority to implement the agreement.
A revised US Food and Drug Administration proposal to let more compounded drug products cross state lines has prompted new hand-wringing over how states will make sure compounding pharmacies do not engage in an "inordinate" amount of interstate activity.
US pharmaceutical industry and compounding pharmacy groups weighed in on FDA’s revised memorandum of understanding on interstate compounding. Respondents said...
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.
