In this week’s news the FDA issues 48 new guidance docs for generics, ICMRA stresses need for team work during COVID-19 and more!
Suite of new US FDA product specific guidelines for generic drugs
The US FDA has released 48 product-specific guidances (PSGs) that include recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs).
Thirteen of the documents – details of which are provided in the Federal Register – cover “complex generic products,” which are non-branded medicines that contain a complex active ingredient, or have a complex formulation, complex route of delivery, or complex drug device combinations.
Collaboration key to aiding industry of quality during pandemic says ICMRA
The International Coalition of Medicines Regulatory Authorities (ICMRA) – whose represents regulators in major markets – made the statement last month, setting out the steps that members have taken to align efforts during the COVID-19 pandemic.
The organisation stressed the importance of collaboration in areas like drug quality, explaining: “The combination of product and process understanding with an effective PQS, combined with open, and continuous communication between stakeholders, allows regulators to utilise greater regulatory flexibility when approving manufacturing changes.”
CDER updates on efforts during COVID
Finally, the CDER has shared more details of its efforts to meet user fee goals during the pandemic. The update includes more details of its facility inspection activities.
Also in the news
The Pinksheet looked at the FDA’s emerging technology programme which will now “graduate” bioprocessing systems with which it has gained “sufficient” experience.
Amgen has started building a manufacturing plant in New Albany, Ohio. According to a press statement, the facility will make medicines for the US market.