In this week’s news, FDA and industry talk fees, EMA updates on Covid-19 vaccine hack and more…
US FDA and industry discuss fees
The FDA and the CDMO and drug sectors met to discuss further details of PDUFA VII with a focus on user fees.
The meetings – which took place on November 20 and December 11 – are the latest round of talks covering the legislation, which will cover the fees the FDA collects from drug firms between 2023 and 2027.
Talks focused on the FDA’s drug safety system, which has been modernized during PDUFA VI. Participants also spoke about “how FDA post-market processes address health disparities and representativeness and how new information and additional research affects FDA review of black box warnings,” according to the agency.
In the official notes from the meeting the FDA said it “described how the foundation for a capacity planning adjustment (CPA) methodology was developed during GDUFA II and how the proposed CPA methodology could continue to be developed and refined.
The agency also said it provided more information regarding the inflation adjustment proposal, to more accurately account for program costs, as well as the proposed operating reserve adjustment and the proposed elimination of a limitation on allowable fee expenditures.
EC open to remote audits for device firms during pandemic
The European Commission (EC) says remote audits are an option for medical device and in vitro diagnostic manufacturers during the pandemic.
The EC announced the move last week, explaining the temporary step was prompted by “exceptional and unforeseen circumstances caused by the COVID-19 crisis.”
The Commission said, “Member States, as well as notified bodies and other stakeholders, have informed the Commission that travel and quarantine restrictions imposed in response to the COVID-19 pandemic, both in Member States and non-EU countries, have significantly affected notified bodies’ ability to conduct on-site audits on the premises of manufacturers and their supplies and/or subcontractors.”
EMA updates on Covid-19 related hack
Some of the Covid-19-related documents hackers stole from the EMA in December have been posted online to the agency.
According to the agency’s latest update, “the ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines belonging to third parties have been leaked on the internet.”
The EMA did not disclose details, but did say “the European medicines regulatory network remains fully functional and timelines related to the evaluation and approval of COVID-19 medicines and vaccines are not affected.”
Also in the news
Oncorus has signed a 15-year lease to build a state-of-the-art, 88,000 square foot viral immunotherapy clinical manufacturing facility in Andover, Mass.
Bloomberg reports Moderna has discarded 400,000 doses of its experimental Covid-19 shot after a filtration issue compromised the product.
European Pharmaceutical Manufacturer quizzed Recipharm and Metrics on challenges facing the oral solid dosage form contracting sector.
Bioprocess Insider reports the US FDA has issued a complete response letter to Novartis for Leqvio (inclisiran) due to ‘unresolved facility inspection-related conditions’ at its CDMO, Corden Pharma.
Some developments of note in the contracting sector:
Novan has hired Catalent to make an intranasal formulation of berdazimer sodium for its COVID-19 program. Under the deal the CDMO will support of chemistry, manufacturing and control (CMC) activities.
Radius Health has entered into agreements with Endo Ventures to register, commercialize, and distribute abaloparatide – a treatment for postmenopausal women with osteoporosis – on an exclusive basis in Canada.
Fujifilm Diosynth Biotechnologies plans to invest in a third viral vector production facility citing surging demand.