In this week’s news, US FDA announces revision plan, US House calls for FDA budget hike, Covid-19 trial rules rejigged and more…
Planned US FDA regulation changes will impact pharmas and CDMOs
The US FDA published a list of upcoming regulatory goals, some of which will impact the contract manufacturing sector.
The agency shared its list last week. It includes a proposal to set minimum current good manufacturing practice (cGMP) requirements for “outsourcing facilities” involved in drug compounding.
The FDA also said it plans to revise rules surrounding the production of position emission tomography (PET) drugs – which are radioactive drugs used in patient scanning – to reflect changes to the USP.
CDMOs involved in the collection of blood and blood products destined for use in the production of medicines are also likely to be impacted by regulatory changes.
The FDA plans to permit limited exceptions to certain donor eligibility and donation suitability requirements to provide more flexibility to accommodate advancing technology.
US politicians call for FDA budget of $3.2bn
The US House Committee on Appropriations’ Subcommittee on Agriculture, Rural Development, Food and Drug Administration says the FDA will need $3.2bn from the Government in 2021, up $40.8m on 2020.
The proposed increase – which is smaller than last year’s hike – is to fund the agency’s oversight of drugs and food.
The committee argue the extra funds are needed to support medical product development acceleration, the advancement of influenza vaccine manufacturing technology and – predictably – outbreak response.
Committee chairwoman Nita Lowey said the budget would provide a “$31 million boost to continue to review therapies – and one day, vaccines – for COVID-19, sooner rather than later.”
US FDA rejigs consent rules for Covid-19 patients
US FDA has revised its guidance on how pharmas and CDMOs trialling SARS-Cov-2 vaccines and Covid-19 drugs can obtain consent from patients in isolation.
The revision makes clear that – in the event they cannot enter the rooms of Covid-19 patients in isolation – trial staff can review consent forms via video conference. Confirmation can be verbal as long as it is accompanied by a photograph of the signed form.
Trial staff can also obtain consent in the event photographs cannot be sent if a witness attests to the patient’s signature.
Digital Biomanufacturing Needs a Digital Supply Chain
Digital biomanufacturing is best applied to the entire supply chain according to an expert who spoke with GEN.
Manufacturing digitisation has been deemed challenging in the past, but if implemented as a business plan it could prove extremely impactful on the top and bottom line, according to Cate Rasche from Miebach Consulting’s pharma and life sciences center of excellence.
Industry 4.0 will give the biopharmaceutical industry the opportunity to increase efficiency and create consistency and effectiveness across the production of products.
US FDA says platforms can speed COVID-19 jab development
In the latest guidance document released by the US FDA for firms developing vaccines against Covid-19, the FDA announced the trial data the firms will need to provide. They also mentioned developers must seek approval the “traditional way” due to a lack of surrogate endpoints that could predict the clinical benefit of a vaccine for Covid-19.
The agency goes on to explain how production platforms could help speed the production of treatments for Covid-19. According to the FDA, “vaccine development may be accelerated based on knowledge gained from similar products manufactured with the same well-characterised platform technology.” See more at Bioprocess Insider.