In this week’s news, the US will continue risk-based model for overseas plant inspections, the FDA call for input on draft guidance and more.

US FDA will maintain risk-based approach for overseas inspections

The US FDA will continue to use a risk-based approach to choose which firms to inspect next and continue leveraging mutual recognition agreements (MRAs) with other regulators.

The plan was outlined by Alonza Cruse, director of FDA’s pharmaceutical quality operation, at the ISPE Aseptic Conference.

According to a report by RAPS, Cruse told the virtual delegates that, while the FDA is “getting our staff up and out there” for domestic inspections, it will maintain a risk-based approach to prioritize overseas facility audits.

FDA calls for input on DSCSA verification system guidance draft

The FDA has called for industry comment on its draft guidelines for verifications systems that are required under the Drug Supply Chain Security Act (DSCSA).

The guidance – which was published in a post on the agency’s site – covers what system manufacturers, re-packagers, wholesale distributors and dispensers must have in place to comply with new drug supply chain laws.

The FDA wrote “this draft guidance covers the statutory verification system requirements that include the quarantine and investigation of a product determined to be suspect and the quarantine and disposition of a product determined to be illegitimate.”

CAR-T and gene therapy draft guidelines

In other news, the FDA has put together two draft guidance documents on the development of human gene therapy products that incorporate genome editing of human somatic cells and chimeric antigen receptor (CAR) T cell products.

 

Also in the news

RAPS covered the industry response to the EMA report on the first five years of the PRIME scheme, which is designed to encourage the development of drugs for unmet needs.

Inside Health Policy looked at US Government efforts to encourage local drug production. According to the article, industry groups say the provisions will have little to no effect.

The Pink Sheet reported on US efforts to sure up drug supply chains. A National Academies expert panel says transparency – not a pandemic-induced rush to on-shoring requirements – would be the best way to mitigate against, and respond to, drug shortages.

The US FDA has published a report on science activities related to generic drugs.

Politico reported that advocacy groups want the Biden administration to take a more active role in building infrastructure to produce mRNA vaccines.

KHN analysed the international drug industry’s response to sanctions imposed on Russia as a result of Vladimir Putin’s invasion of Ukraine.

 

CDMO trends

Some developments of note in the contracting sector: 

PCI Pharma Services has selected Cytiva as their technology supplier. Under the deal, PCI will install a Microcell Vial Filler and an SA25 Aseptic Filling Workcell in San Diego, California, and a Microcell in Melbourne, Australia.

Singota Solutions has teamed with Langham Logistics to provide supply chain solutions to the global biopharmaceutical market.

Lonza has completed the expansion of its pharmaceutical ingredients (API) manufacturing site at Nansha, China. 

Curia will work with the Biomedical Advanced Research and Development Authority (BARDA) and the US Army Contracting Command to support the domestic production of injectable medicines. 

Novartis has hired Carisma Therapeutics to manufacture the HER 2 targeted CAR-M cell therapy for the treatment of solid tumours. Under the deal, the Carisma process will be transferred to the Novartis site in Morris Plains.