The End Of The FDA Approvals Boom? Fewer Applications Are A COVID-19 Consequence

Applications for US FDA approval are lower than in recent history, portending a lean 2021.

Down arrow on pavement

Fewer applications for approval have been submitted to the US Food and Drug Administration through May of 2020 than in recent years, likely representing the leading edge of the impact of COVID-19 on drug development – and the end of an approvals boom.

Where an average of over 70 new drug and biologic applications and efficacy supplements were submitted between January and May...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Product Reviews

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

CAR-T REMS Removal Should Boost Access, But Long-Term Follow-Up, Black Box Remain

 

The REMS removal and labeling changes should open up CAR-T treatment to many more US patients, although other regulatory hurdles and safety language that experts had wanted removed still stand.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US

US CDC Vaccine Committee Revives Thimerosal Debate: A Portent Of Things To Come?

 

The new Advisory Committee on Immunization Practices voted for new recommendations on the decades-old thimerosal safety issue and lays intellectual groundwork to revisit other past controversies and decisions.

More from Pink Sheet

Swissmedic Appoints Trivigno As New Agency Head From 2026

 

Vincenza Trivigno will take over as executive director from Raimund Bruhin, who is retiring after over seven years in the post.

New EFPIA President Hopes ‘Sanity Will Prevail’ In EU Pharma Reform Dialogs

 

Stefan Oelrich, the newly-announced president of European pharma industry federation EFPIA says the EU pharma reform is “not an improvement on the status quo” in its current form.

UK Pilots Faster Setup Of Early Phase Oncology Trials

 
• By 

Oncology trial sponsors in the UK are being invited to participate in a pilot that aims to tackle duplication and variation in pharmacy reviews, which are an important part of setting up clinical trials in the National Health Service.