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.

Phage therapy firm Armata Pharmaceuticals has entered into a lease agreement to build a research and development and GMP manufacturing facility in Los Angeles. See press release.

Strides Pharma is taking over a former Endo Pharmaceutical generic drug manufacturing plant in New York according to the Business Journal.

German drug firm Merck will help Saudi Arabia-based SaudiVax design a multi-modality manufacturing facility to localize manufacturing of biologics and vaccines. See press release.

CDMO trends

Some developments of note in the contracting sector:

PCI is building a facility in Bridgewater, Massachusetts to provide clinical storage, distribution and packaging services to meet growing regional demand. See press release.

Selkirk Pharma has acquired 10.7 acres of land adjacent to its facility in Spokane, Washington and announced plans to expand the site.

Lonza has bought an exosome manufacturing facility located in Lexington, Massachusetts from Codiak BioSciences. See press release.

iBio has purchased the manufacturing facility in Bryan, Texas it previously operated under a lease from two affiliates of Eastern Capital Limited. See announcement.

Samsung Biologics says the plant it is building in Songdo, South Korea will be partially operational by the end of 2022 and fully GMP-ready in 2023, See statement.