Regulatory Focus™ > News Articles > Regulatory Recon: FDA to Hold Meeting on Off-Label Drug Use (7 May 2015)

Regulatory Recon: FDA to Hold Meeting on Off-Label Drug Use (7 May 2015)

Posted 07 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA to Hold Meeting on Off-Label Drug Use (7 May 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.

In Focus: US

  • Under pressure, FDA to hold public meeting on off-label use (Reuters)
  • J&J to consult ethicists on requests for experimental drugs (Reuters) (WSJ-$) (NYTimes)
  • FDA reviewers propose routes to Ebola vaccine approval (BioCentury)
  • FDA reveals 142 cases of tainted scopes (LATimes)
  • FDA warns Smith & Nephew on Truclear Ultra morcellator (MassDevice) (FDA) (Fierce)

In Focus: International

  • Applying regulatory science to neonates: International Neonatal Consortium Launched (EMA)
  • A new era of transparency: UK pharma prepares to publish doctor payments (PharmaPhorum)
  • Clinical trial transparency improving, ABPI study finds (PharmaTimes)
  • EU Citizens Initiative on Vivisection Moves Forward (EC)
  • China Said to Probe Ex-Official Who Oversaw Clinical Drug Trials (Bloomberg)
  • Health Canada Finalizes Recommendations on Third-Party Data in Drug Submissions (FDAnews-$)

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US: Pharmaceuticals and Biotechnology

  • Under pressure, FDA to hold public meeting on off-label use (Reuters)
  • J&J to consult ethicists on requests for experimental drugs (Reuters) (WSJ-$) (NYTimes)
  • FDA reviewers propose routes to Ebola vaccine approval (BioCentury)
  • Georgia, Tennessee Sign Biosimilar Interchangeability Laws (Press) (Press)
  • ‘How do you tell a kid he’s not going to grow up?’ DMD Patient's Fight With FDA (WashPost)
  • New FDA Import Alert on Indian Drug Manufacturer Pan Drugs (FDA)
  • Ala. Generics Injury Ruling May Still Sway Other States (Law 360-$)
  • GSK sees little prospect of U.S. generic Advair in 2016 (Reuters)
  • Progress and Hurdles for Follow-on Biologics (NEJM)
  • Precision Medicine Approaches Peak Hype (Forbes)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • Roche says FDA grants breakthrough therapy designation for venetoclax (Reuters) (SCRIP-$) (Press)
  • BMS Releases PhIII Data on Long-Term Benefit of Nulojix (Press)

US: Pharmaceuticals and Biotechnology: General

  • Alexion-Synageva Deal Shows Lure of Rare-Disease Drugs (WSJ-$)
  • Financing Breakthrough Medicine: Opportunities and Obstacles (NCPA)
  • Top Hill Staffer Says CMS Breakthrough Coverage Pulled Due to Cost (Gray Sheet-$)

US: Medical Devices

  • FDA reveals 142 cases of tainted scopes (LATimes)
  • FDA warns Smith & Nephew on Truclear Ultra morcellator (MassDevice) (FDA) (Fierce)
  • Startup Transcend to submit PMA in second half for glaucoma micro-stent (Fierce) (MassDevice)

US: Dietary Supplements

  • Homeopathic Divide: FDA Talks Pre-Market Approval As Industry Floats Label Changes (Pink Sheet-$)
  • As Jury Trial Approaches, USPlabs Says DMAA Supplement Didn’t Cause Soldier’s Death (NPI)
  • How Fake News Articles And Lies About Billionaires Were Used To Market An Iffy Dietary Supplement (Forbes)

US: Assorted And Government

  • FDA Science Forum to Focus on Emerging Technologies (FDA)

Upcoming Meetings and Events

Europe

  • Applying regulatory science to neonates: launch of the International Neonatal Consortium (INC) (EMA)
  • A new era of transparency: UK pharma prepares to publish doctor payments (PharmaPhorum)
  • Clinical trial transparency improving, ABPI study finds (PharmaTimes)
  • EU Citizens Initiative on Vivisection Moves Forward (EC)
  • Pharma firms way ahead in requesting access to EMA documents (SCRIP RA-$)
  • Falsified Humira found in Germany (SecuringIndustry)
  • Addressing the challenges faced by European Bio-pharmaceutical sector (EFPIA)

India

  • Monitoring sales of prescription drugs on e-commerce websites tough: Analysts (Times of India)

China

  • China Said to Probe Ex-Official Who Oversaw Clinical Drug Trials (Bloomberg)

Canada

  • Health Canada Finalizes Recommendations on Third-Party Data in Drug Submissions (FDAnews-$)

Other International

  • Venezuela says probing drugmakers for improper use of hard currency (Reuters)

General Regulatory And Interesting Articles

  • Elemental Impurities – Their Impact on Drug Quality (USP)
  • The ISO 9001:2015 Change Train is Gathering Steam (GxP)

Regulatory Reconnaissance #552 – 7 May 2015

Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory news stories from around the globe. Each weekday morning, we aim to bring you the latest highlights of new approvals, meetings, legal and political developments, regulations and guidance, and the latest trends with the potential to impact regulatory affairs professionals and the industry in which they work.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

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