REGULATORY ARTICLES

• After Hikma: A Transatlantic View Of Skinny Labels And Pharma Strategy

  The Hikma ruling clarifies U.S. skinny-label protections, but divergent European rules complicate patent, launch, and litigation strategies, according to legal experts. 

• An Incomplete Response: Will The FDA Finish What It Started With Real-Time CRLs?

  FDA’s real-time CRL releases face legal and operational hurdles. Could AI-assisted redaction make transparency faster and more consistent?

• An Express Lane To Clinical Testing? FDA's Expedited IND Pilot Program

  FDA’s Expedited IND pilot pairs developers with expert advisers and uses rolling submissions to improve IND quality and accelerate Phase 1 trials, writes Luke Nguyen.

• MFN Cuts Manufacturer Prices, But Savings Still Face A Longer Journey

  MFN cuts manufacturer drug prices, but transparency across PBMs and pharmacies is needed to ensure the savings reach patients, writes Paul Pruitt.

• Wall Street Is Wary Of NAMs — And For Good Reason: What Happens To Yesterday's Drugs?

  Part 2 follows the consequences into Wall Street, asking what better evidence could mean for pharmaceutical valuations and, ultimately, drugs already in the portfolio.

• Pharmacovigilance Is Not A Checkbox: Rethinking Safety Monitoring From Day One

  Cell and gene therapies demand a pharmacovigilance approach built from the ground up, not adapted from frameworks designed for conventional drug products.

• July Update — U.S. Generic Drug Tariffs: Implications For Pharma And Outsourcing

  Mathini Ilancheran updates us on how delayed U.S. tariffs on generic drug imports could reshape supply, sourcing, and trial planning.

• Psychedelics EO May De-Risk Innovation, But Data Is Still King

  A recent Executive Order (EO) de-risks psychedelic drug development by clarifying regulations, but scalable treatment models and rigorous data collection remain critical.

• Beyond The Fine Print: OPDP's 2026 DTC Letters Redefine Net Impression

  FDA’s OPDP untitled letters show rising scrutiny of DTC ads’ overall impression on consumers and urge companies to balance benefit claims with clear product risks.

• Understanding FDA's Plausible Mechanism Framework For Genetic Medicines

  FDA’s draft “plausible mechanism” framework gives individualized genetic therapies a clearer path to market, but questions remain, write experts at Morrison Foerster.