In this week’s news, FDA urged to do more on inspections, EMA guides on PRIME approval process and more…

GAO wants US FDA to address COVID-19 inspection backlog

The US Government Accountability Office (GAO) wants the FDA to review its approach to inspections and come up with a plan to address the current backlog.

The GAO called for action in a report this week, urging the agency to find better ways of coping with disruption caused by the pandemic.

It wrote ““Prior to COVID-19, FDA typically conducted more than 1,600 inspections of foreign and domestic drug manufacturing establishments each year, but inspections have been reduced significantly.

“Alternative tools have helped FDA continue its oversight, but are not a comprehensive or long-term substitute for FDA inspections.”

According to the GAO the FDA only conducted three “mission critical” inspections of foreign manufacturing plants between March and September last year, whereas it carried out more than 600 in the equivalent period in 2018 and 2019.

Also, the FDA inspected just 52 US facilities in the same period, down from around 400 in the comparable period in either of the two prior years.

The GAO called on the FDA to assess whether alternative inspection tools could provide the information needed to supplement regular inspections. It also warned the agency to plan for the mounting inspection backlog.

EMA guides on PRIME approvals

The EMA has released draft guidance to assist drug developers seeking approval through the Priority Medicines (PRIME) scheme.

The guidelines address challenges related to product quality, manufacturing development and data requirements identified by users of the PRIME scheme during a workshop held in 2018.

The document takes the form of a toolbox that pulls together regulatory tools and scientific guidance. The EMA said the aim is to help firms compile submission dossiers more complete filings more quickly

CBER publishes guidance plan for 2021

The FDA’s Center for Biologics Evaluation and Research (CBER) has issued details of the guidance documents it plans to publish in 2021.

The list contains 14 documents, half of which will be drafts. Some have already been issued, including advice on investigational COVID-19 convalescent plasma, manufacturing and considerations for licensed and investigational cell and gene therapies for the disease.

Also in the news

Biologics focused CDMOs are hedging their bets and retaining small molecule manufacturing capacity according to a report by Bioprocess Insider.

The contract manufacturing sector is embracing digital technology according to experts quizzed by Pharma Times.

STAT looked at the US FDA use of AI enhanced analytical systems medical devices and products.  The authors examine concerns about the clinical data on which the agency’s decisions are based.

The Pink Sheet looked at FDA vaccine review monitoring and the challenges associated with the emergence of new strains of SARS-CoV-2, the virus that causes COVID-19.

The publication also examined agency review timelines, labelling them and standard, priority and oncology.

US industry group PhRMA wants Japan to make greater use of real wold data in decision and policy making, Read more at Pharma Japan.

The Chinese syringe industry is struggling to keep up with demand driven by expanding COVID-19 vaccination programmes. Read more at Reuters.

The US FDA is preparing to share data from remote facility assessments with regulators elsewhere according to a report by the Pink Sheet.

CDMO tends

Some developments of note in the contracting sector:

Catalent says its annual revenues were boosted by more biologics and COVID-19 related work. See more at Fierce Pharma.

Wuxi STA has acquired a Bristol Myers Squibb manufacturing facility in Couvet, Switzerland. See press statement.

Verity Pharma and India’s Serum Institute have been contracted to distribute AstraZeneca’s COVID-19 vaccine in Canada according to a Reuters report.

Humanigen has wired two CDMOs to help with production of its candidate anti-COVID-19 monoclonal antibody lenzilumag. The firm signed contracts with Emergent Biosolutions and Avid this week.