1. Pink Sheet
  2. >>Geography
  3. >>North America
  4. >>United States

FDA Reprint Policy Expands To Clinical Practice Guidelines, Medical Reference Texts

 
• By Brenda Sandburg

FDA has revised, but not loosened, its 2009 final guidance on good reprint practices for distribution of journal articles on unapproved uses of approved drugs and devices.

FDA is revising its guidance about the proper procedures for distributing journal articles about unapproved uses of approved drugs and medical devices to healthcare providers. The new draft document is not much different from the agency’s 2009 final guidance on good reprint practices, but includes new sections on how these practices apply to medical reference texts and clinical practice guidelines.

The agency announced the availability of the draft guidance, “Distributing Scientific and Medical Publications on Unapproved New Uses – Recommended Practices,” in a Federal Register notice slated for publication on March 3

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
Start Free Trial

Already a subscriber?

More from United States

Novavax’s COVID-19 Vaccine Label Narrowed After Political Officials Intervened

 
• By Sarah Karlin-Smith

The label that Novavax's COVID-19 vaccine was slated to receive before political officials held up the approval was broader than was granted 16 May.

Biomarker Negativity At Issue In Pfizer Bid To Broaden Talzenna CRPC Claim

 
• By Bridget Silverman

The FDA questioned Pfizer’s reliance on a “large, incompletely defined” subgroup of castration-resistant prostate cancer patients without known HRR gene alterations in its review of the proposed expansion of Talzenna’s first-line indication for HRR-mutated CRPC to an all-comers population.

UroGen’s Mitomycin: Are Randomized Trials For Bladder Cancer Necessary?

 
• By Sue Sutter

The Oncologic Drugs Advisory Committee will vote on the risk-benefit of UGN-102 for low-grade, intermediate-risk, non-muscle invasive bladder cancer based on data from a single-arm trial, but the FDA also seeks input on requiring randomized studies for future treatments.

Life After Loper: Vaping Case Shows US FDA Retains Considerable Deference

 
• By Craig Bleifer, Royce DuBiner, Max Bogost, Michael Brody, and Allyson Maur

A US Supreme Court ruling in favor of the agency in an e-cigarette case has implications for drugs and other medical products as the justices decided not to disturb the FDA’s ‘change in position’ authority, while also creating a complex new landscape.

More from North America

US FDA COVID-19 Booster Strategy May Not Be As Controversial As It Seems

 
• By Michael McCaughan

US FDA Commissioner Martin Makary’s call for placebo-controlled trials to confirm the efficacy of COVID-19 boosters is drawing a lot of criticism, but former Commissioner Robert Califf also supported the idea.

US FDA Legislative Lead Calls For User Fee Reforms As Renewal Talks Near

 
• By Sarah Karlin-Smith

Deputy FDA Commissioner Grace Graham acknowledged the importance of user fees, while also calling for restructuring. She also said part of MAHA's mission is to reexamine uses of drugs not supported by data.

Smoldering Myeloma Endpoint Questions Carry J&J’s Darzalex Faspro To US FDA AdComm

 
• By Bridget Silverman

The US FDA seeks advice on the clinical meaningfulness of the endpoints of J&J’s AQUILA trial in smoldering multiple myeloma, highlighting the pitfalls of being the first candidate for the precancerous condition.