In this week’s news, US CDER talks about inspections during COVID, US FDA sets out to boost complex generics and more…
US CDER outlines pandemic inspection strategy
The US FDA’s Center for Drug Evaluation and Research (CDER) conducted and accepted upon nearly all the inspection applications it received so far in 2021.
The CDER shared data from its manufacturing inspection programme this week, framing its efforts against a backdrop of more than a year of disruption caused by the pandemic.
The agency cited use of alternative methods as key to its efforts to maintain oversight, explaining that it had reduced the number of preapproval inspection it carried out.
“As a result of utilizing these alternative approaches, CDER completed facility assessments to meet UFA dates by reducing the need to conduct PAIs 58% of the time in FY2020 Q3, 64% of the time in FY2020 Q4, 56% of the time in FY2021 Q1, and 48% of the time in FY2021 Q2. FDA has also enhanced use of sampling and testing drugs being marketed.”
US FDA sets sights on supporting complex generics
The US FDA has shared details of its efforts to support generic drug firm and CDMO, citing complex generics as a key focus going forward.
The agency wrote about generics in a blog post this week, explaining that “Advancing complex generic drug development is an important part of FDA’s goal to help make sure patients have access to a broad range of potentially cost-saving medicines.
It said that GDUFA III – the generic user fee act, the reauthorization of which is currently being discussed with industry – is likely to include “initiatives to support complex generic development and assessment.”
US FDA finalizes QIDP antibiotic programme benefits
In other news the FDA has published its final guidance on its qualified infectious disease product (QIDP) designation program.
The programme – which is part of the Generating Antibiotic Incentives Now (GAIN) section of the 2012 Food and Drug Administration Safety and Innovation Act (FDASIA) – affords developers an extra five years of patent protection to encourage the development of antibiotics.
Also in the news
STAT looked at challenges facing COVID-19 vaccine suppliers in India and the impact they may have on the wider world.
US Lawmakers want to encourage the pharmaceutical industry to invest in antibiotic development according to Inside Health Policy.
Reuters covered alleged document tampering at a US vaccine manufacturing facility.
Moderna announced an agreement with Gavi, the Vaccine Alliance to supply up to 500 million doses of its COVID-19 vaccine, including an initial 34 million doses to be delivered this year. See press release.
Endpoints reported on Cellares’ efforts to secure funding for its Cell Shuttle technology, which is billed as a portable cell therapy production facility.
Packaging Digest reported Quantis’ launch of eQopack, a software as a service (SaaS) tool that embeds eco-design into the packaging development process.
Some developments of note in the contracting sector:
Catalent has acquired Promethera Biosciences cell therapy subsidiary, Hepatic Cell Therapy Support SA, including its facility in Gosselies, Belgium that will be the CDMO’s new plasmid DNA manufacturing base.
Woodstock Sterile Solutions has vaccinated more than 200 of its employees for COVID-19 at its production facility in Woodstock, Illinois.
Enteris BioPharma has expanded is Boonton, NJ manufacturing facility and launched a CDMO business that will specialise in difficult to formulate BCS III and IV compounds, including peptides and highly potent drugs.
AMRI has expanded its scale and compound handling capabilities at its facilities in Albany, New York; Grafton, Wisconsin and Glasgow, Scotland.
Sterling Pharma Solutions says ADC Therapeutics SA, has received FDA approval for the antibody drug conjugate (ADC) Zynlonta (loncastuximab tesirine-lpyl), which was developed at its facility in Deeside, Wales.