In this week’s news, FDA outlines regulations plan, Japan guides on remote facility inspections and more…

New FDA guidelines impacting the CDMO sector due in 2021

CDMOs that compound drugs can expect a raft of FDA regulations in 2021 according to the publishing schedule published by the CDER this week.

The FDA has had oversight of CDMOs compounding drugs in “Outsourcing” facilities since 2013 under the Drug Quality and Security Act.

According to the 2021 publication plan, the FDA will issue guidelines on safety, container labels and use of designs that minimize medication errors.

The contracting should also look out for new guidelines on chemistry, manufacturing and controls (CMC). According to the CDER the document will cover benefit-risk considerations for product quality assessments.

In total the CDER plans to publish 105 guidance documents this year, all but 42 of which were due to be published last year.

More generics firms seeking priority and competitive designation

The number of priority and competitive generic therapies (CGT) approved or under review has increased markedly in recent years according to the FDA.

Data published by the agency suggest three years into the second Generic Drug User Fee Amendments (GDUFA II) program generic drug firms continue to pursue both the priority and competitive therapy designations.

GDUFA II introduced both designations. The priority program is designed to shorten reviews for certain ANDAs and the CGT designation is intended to increase competition for drugs with only one generic on the market.

Japan outlines remote inspection plan

The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has shared details of its procedure for remote compliance inspections related to drugs and regenerative products.

According to the document drug firms selected for remote inspection will need to present documentation for PMDA staff review. The agency will raise any concerns it has following the review via video conference interview.

The PMDA includes information on video conferencing systems used to enable remote inspections and scanning procedures for paper documents.

Also in the news

Reuters looked at industry struggles to make COVID-19 vaccine manufacturing commitments amid concerns about hoarding and nationalism.

The Guardian covered growing concerns that despite COVID-19, the pharmaceutical industry has not done enough to prepare for predicted future pandemics.

Harvard Law looked at the dynamics shaping the biosimilars sector in the US. According to the authors three new products were launched in the US despite disruption caused by the pandemic.

The US FDA has rescheduled a delayed workshop for medical devices for children until next month according to a report by Medtech.

Berry Global Healthcare has launched a dual-port blow fill seal closure for large volume parenteral applications. Read more at Packaging News.

CDMO tends

Some developments of note in the contracting sector:

The API manufacturing industry is being reshaped by demand for ingredients for COVID-19 therapeutics and vaccines, continued growth of the oncology market and competition in the generics space according to a Global Pharma Insights report.

Rooster Bio and Sartorius have teamed up to set up a manufacturing service for hMSC based therapies. Read more at Bioprocess Insider.

Lonza says it will take three months to ramp-up production of COVID-19 vaccines on new lines installed at plants in Visp, Switzerland. Read more at Reuters.

Humanigen has contracted Emergent for COVID-19 mAb candidate. Read more at Fierce Pharma.

Cognate Biosciences has announced plans to expand cell and gene therapy production capacity in the US and Europe. See press statement.

Innovation has a role to play in biopharmaceutical contracting, but industry needs to get used to handling data according to a report by GEN.