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M. Nielsen Hobbs

Executive Editor

Washington DC
M. Nielsen Hobbs has more than 20 years of experience covering the pharmaceutical industry, and writes frequently about the intersection of business, regulation, science and politics. Before joining the “The Pink Sheet” he worked for Congressional Quarterly. Hobbs enjoys discussing BB-8 almost as much as he enjoys talking about 351(k).

Latest From M. Nielsen Hobbs

FDA Airs ‘Concerns’ Over IP Barriers

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

Intellectual Property Policy

US FDA’s Patent ‘Concerns’ Include Thickets, Product Hopping, And Evergreening

Senators press for sharing of FDA applications with PTO as Woodcock letter seeks collaboration on everything from PTAB to patent term extensions to ‘possible misuse of the patent system.’

Intellectual Property Generic Drugs

Pink Sheet Podcast: Top US FDA Vaccine Leaders Retire, COVID-19 Booster Shots, JAK Inhibitor Safety

Pink Sheet reporters and editors consider the leadership shake-up at the FDA Office of Vaccines Research and Review, the COVID-19 vaccine booster shot debate, and the impact of new safety measures for several JAK inhibitors.

Vaccines Leadership

Pink Sheet Podcast: Breakthrough Therapy CRLs, Statins While Pregnant, COVID-19 And Clinical Trials

Pink Sheet reporters and editors discuss increasing complete response letters for breakthrough designees, FDA changing course on statin use during pregnancy, and efforts to use pandemic innovations to improve clinical research going forward.

Drug Review Clinical Trials

Pink Sheet Podcast: Aduhelm Label Change, First Half Drug Approvals, FTC Investigative Power

Pink Sheet reporters and editors discuss the implications of Aduhelm’s updated indication, CDER’s new drug approvals in the first half of 2021, and an FTC policy change that will make investigating pharma easier.

Neurology Approvals

Ultra-Rare Disease Approvals By US FDA Could Take More ‘Mechanistic,’ Less ‘Empirical’ Approach

Acting Commissioner Woodcock says ‘we weren’t as flexible as we should be’ and notes that center directors are reviewing the criteria for rare disease assessments.

Rare Diseases Drug Approval Standards
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