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Back To Normal-ish: What To Expect As Pharma Resumes In-Person Gatherings

 
• By Nielsen Hobbs

With the mask mandate now lifted for air travel and the grimmer milestone of one million Americans dead from COVID approaching, the Pink Sheet looks back at the generic trade association’s annual meeting to see what business gatherings may look like going forward.

THIS WAS THE FIRST IN-PERSON ANNUAL MEETING FOR AAM CEO DAN LEONARD, WHO JOINED THE TRADE GROUP IN AUGUST 2020.
THIS WAS THE FIRST IN-PERSON ANNUAL MEETING FOR AAM CEO DAN LEONARD, WHO JOINED THE TRADE GROUP IN AUGUST 2020. • Source: Nielsen Hobbs

Multinational corporations bemoaned their underdog status and Doug Long made a Yogi Berra joke. If it hadn’t been for the hotel staff in masks and the six-piece “protection kit” at every chair, the Association for Accessible Medicines’ annual meeting in Orlando earlier this year might have seemed unchanged, despite the two-year break from the gathering imposed by COVID.

With the mask mandate now lifted for airflights and the grimmer milestone of one million Americans dead from COVID approaching,...

More from Generics

US FDA Maintaining Approval Output Despite Losing Staff

 
• By Derrick Gingery

Reviewers were not targeted by the FDA reduction in force, but increasing attrition and difficulties hiring new staff still do not seem to have impacted new and generic drug approval totals.

Generic Drug Industry Seeks More US FDA Communication Reforms In GDUFA Renewal

 
• By Sue Sutter

Enhancing the consistency and clarity of information requests and discipline review letters, and improving assessment milestone communications are key areas targeted by generic drug makers for user fee program negotiations.

Aurobindo Expects US FTC Will Allow Lannett Acquisition

 
• By Vibha Ravi

Aurobindo is confident its planned Lannett acquisition will meet US FTC standards after an attempt to acquire Sandoz assets was nixed in 2020. The deal also could widen Aurobindo’s US manufacturing presence.

US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
• By Derrick Gingery

A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

More from Conferences

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 
• By Derrick Gingery

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

Post-BIO Podcast: Thoughts From The Frontlines

 
• By Sarah Karlin-Smith, Mandy Jackson, and Mary Jo Laffler

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 
• By Sarah Karlin-Smith

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.