In this week’s news, FDA outlines inspection plan for coronavirus vaccine plants, MHRA says real-world data has trial role and more…
US FDA plans flexible approach for Covid vaccine plant assessments
The US FDA will take a flexible approach when assessing facilities producing emergency vaccines against SAR-CoV-2, the virus that causes COVID-19.
The US regulator shared details of its planned approach in a Q&D document last week.
The document garnered considerable press coverage. According to The Pink Sheet the agency may visit rather than inspect facilities making Covid-19 vaccines for emergency use.
This take was echoed InsideHealthPolicy which reported the agency may not conduct pre-approval inspections of sites that are manufacturing COVID-19 vaccines and that are being considered for emergency use authorization.
“Namely, agency officials have said that FDA will rely on other information to assess manufacturing compliance, including “site visits,” a term that one regulatory lawyer said she’s never before heard FDA use,” IHP wrote.
MHRA explains how real-world data can aid trials
The UK MHRA has offered developers guidance on use of real-world evidence in clinical trials.
According to the document real-world evidence – which it defines at patient data in electronic health records (EHR), and disease and patient registries – can be used in clinical development.
The MHRA said “Use of such pre-existing data sources has the potential for increasing the speed and reducing the cost of development programmes.”
The agency added “RWE can be more representative of the true effects of a treatment in the community and more generalizable than data from the standardised setting of a conventional clinical trial.”
US FDA clarifies on reference drugs in ANDAs
The US FDA has clarified how generic drug companies and CDMOs should work with reference listed drugs in ANDA submissions.
The agency issued final guidelines last week, explaining it was designed to address issues in the draft version that prompted questions from industry.
One topic address is when a reference drug is discontinued and withdrawn from the FDA Orange Book.
The agency said that in such circumstances the applicant can ask to use a different RLD by means of a controlled correspondence rather than via a citizen petition.
US FDA published essential drug and device list
In other news the FDA has published a list of drugs and medical devices it deems essential in response to an executive order from the US Government.
Drugs and devices on the list will be prioritized by federal procurement agencies, with the aim being to source them from local producers.
A total of 223 drugs and biological products and 96 medical devices that have been deemed “medically necessary to have available at all times,” are included on the list.
The document also identifies “critical inputs” – including active pharmaceutical ingredients – needed to make the products.
Read the full FDA statement here.
Also in the news
Pfizer has restructured its SARS-CoV-2 vaccine distribution plan and will no longer use the US Government’s distribution partner, McKesson. Read more at Fiercepharma.
The Center for Infectious Disease Research and Policy has issued a report suggesting how pharmaceutical firms can work to prevent drug shortages during the Covid-19 pandemic.
Bioprocess Insider covered PerkinElmer’s takeover of Horizon Discovery.
Novartis told GEN about its efforts to digitize its manufacturing operations.
Some developments of note in the contracting sector:
Bayer will buy gene therapy developer Asklepios BioPharmaceutical. The deal will include AskBio’s folding stake in Spain based CDMO Viralgen.
The US Department of Defense (DOD), has hired Ology Bioservices to manufacture a novel live attenuated tularemia vaccine.
Servier’s antibody unit Symphogen has extended its therapeutic analysis collaboration with Thermo Fisher Scientific.
Piramal Pharma will buy Navin Fluorine’s stake in their joint-venture Convergence Chemicals, a manufacturer of specialty fluorochemicals used in anesthetics production.
The Stevanato Group has expanded a collaboration with Catalent to include the provision of visual inspection systems to help with potential solutions to the pandemic. The systems will be installed at manufacturing sites in the US and Italy.