Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA Wants Accelerated Approval Pathway for Devices (31 January 2014)

Regulatory Reconnaissance: FDA Wants Accelerated Approval Pathway for Devices (31 January 2014)

Posted 31 January 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • FDA Considering Accelerated Approval Pathway for High-Need Devices (MedPage Today)
  • FDA's Office of Generic Drugs in Massive Effort to Address Post-GDUFA Stakeholder Transparency Concerns (FDA Law Blog) (Pink Sheet-$)
  • Promotions For Black-Box Drugs Aren't Specific Enforcement Targets, FDA Says (Pink Sheet-$)
  • USP and FDA Look to Improve Drug Packaging Standards (Gold Sheet-$)
  • Breakthroughs for Patients, CMC Regulatory Flexibility (Gold Sheet-$)

In Focus: International

  • Why India's audiovisual recording norm for trial consent may shrink patient pool (SCRIP-$)
  • India Battles "Specious" Quality Allegations, Demurs on PIC/S (Gold Sheet-$)
  • Landmark device distribution practice rules on the horizon in China (SCRIP-$)
  • Indonesia Health Ministry Warns Efforts to Pass Halal Certification Law May Limit Treatment Options (Gold Sheet-$)

US: Pharmaceuticals/Biotechnology

  • FDA's Office of Generic Drugs in Massive Effort to Address Post-GDUFA Stakeholder Transparency Concerns (FDA Law Blog) (Pink Sheet-$)
  • Promotions For Black-Box Drugs Aren't Specific Enforcement Targets, FDA Says (Pink Sheet-$)
  • USP and FDA Look to Improve Drug Packaging Standards (Gold Sheet-$)
  • Breakthroughs for Patients, CMC Regulatory Flexibility (Gold Sheet-$)
  • Indiana Senate Passes Biosimilars Legislation (Press)
  • Sanofi sues Eli Lilly over challenge to top diabetes drug Lantus (Reuters) (PMLive) (Fierce)
  • An Old Fashioned Park Criminal Prosecution With Some Twists (FDA Law Blog)
  • Pew: To Take on Superbugs, Prime the Antibiotics Pipeline (Pew)
  • Drugmakers Defend No-Cash Patent Deals Post-Actavis (Law 360-$)
  • Vaccines and Related Biological Products Advisory Committee; Notice of Meeting (FDA)
  • Valeant Pharmaceuticals Announces Approval of Retin-A Micro Microsphere 0.08% (Press)

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

  • Avanir leaps on NDA submission for migraine drug-device combo (SCRIP-$) (Press) (Pharma Letter-$)
  • Amgen's cholesterol fighter succeeds in fifth late-stage study (Reuters) (Bloomberg)
  • Enanta Pharmaceuticals Announces Results from Four All-Oral, Interferon-Free, Phase 3 Studies for the Treatment of Genotype 1 Hepatitis C Virus Infection (Press)

US: Pharmaceuticals and Biotechnology: General

  • Many chronically ill Americans unable to afford food, medicine (Reuters)

US: Medical Devices

  • FDA Considering Accelerated Approval Pathway for High-Need Devices (MedPage Today)
  • WLF Seeks to Overturn "Do Over" FDA Ruling (WLF)

US: Dietary Supplements

  • Study Finds Why Some Supplements Might Be Risky (AP)
  • Plaintiffs Bar Targets Dietary Supplement Efficacy Claims (Law 360-$)

US: Assorted And Government

  • Merck Joins Companies Ending Chimpanzee Research (AP)
  • Summary of TransCelerate's Update to its Risk-based Monitoring Position Paper (Polaris)
  • Big data firm to help NIH's Undiagnosed Disease Program commercialize its genetic analysis techniques (MedCity News)
  • CDISC Announces New Additions to Board of Directors for 2014 (Press)
  • Senator: Regulatory capture a 'threat' to government (The Hill)

Upcoming Meetings And Events

  • 28-29 January 2013: Workshop - Strategies to Address Hemolytic Complications of Immune Globulin Infusions (FDA)
  • 29-30 January 2014: Science Advisory Board to the National Center for Toxicological Research Meeting (FDA)
  • 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Privacy fears over NHS database in aid of medical research (FT-$)
  • Sentinel TAVR Cerebral Protection System Gets CE Mark (MedGadget)

India

  • Why India's audiovisual recording norm for trial consent may shrink patient pool (SCRIP-$)
  • India Battles "Specious" Quality Allegations, Demurs on PIC/S (Gold Sheet-$)
  • Indian API manufacturers also need no-objection certificate for producing particular formulation for export: CDSCO (PharmaBiz)
  • Daiichi Sankyo pledges bold action on Ranbaxy production problems (Reuters)

Japan & China

  • Landmark device distribution practice rules on the horizon in China (SCRIP-$)

Other International

  • Indonesia Health Ministry Warns Efforts to Pass Halal Certification Law May Limit Treatment Options (Gold Sheet-$)

General Regulatory And Interesting Articles

  • H1N-What? Wading Through the Alphabet Soup of Flu Names (Scientific American)
  • Some babies mistakenly injected with oral vaccine (CBS)

Regulatory Reconnaissance #247 - 31 January 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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


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