Regulatory Focus™ > News Articles > Regulatory Recon: FDA Creates New Working Group on Compassionate Use (12 December 2014)

Regulatory Recon: FDA Creates New Working Group on Compassionate Use (12 December 2014)

Posted 12 December 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Creates New Working Group on Compassionate Use (12 December 2014)

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

In Focus: US

  • FDA creates expanded access working group (BioCentury)
  • Actavis Ordered to Continue Selling Old Version of Namenda (Press) (AP) (Pharmalot) (NYTimes) (SCRIP-$)
  • FDA medical device head says time to approve trials is getting shorter (BioFlash)
  • FDA Approves Test to Confirm Presence of Human T-cell Lymphotropic Virus-I/II Antibodies (FDA) (Press)
  • NDA Review ‘Program’ On Track, But Is It Still Doomed? (Pink Sheet-$)
  • Senate makes designer steroids a controlled substance (The Hill)
  • Review: FY 2014 Inspectional Observation Summaries (FDAatty)
  • DoJ Aims To ‘Do Something About’ Crime In FDA-Regulated Industries (Tan Sheet-$)

In Focus: International

  • Investigation Calls EU Device Approval Standards a "Farce" (RadarTV)
  • ICH Reforming In Ways That Could Strengthen Harmonization Process (Pink Sheet-$)
  • Medical Countermeasures That Could Be Procured In Common Under The Joint Procurement Agreement (EC-PDF)
  • India extends price caps to 52 more essential drugs (Reuters) (India Times)
  • AdvaMed demands separate regulations for medical devices (PharmaBiz)

US: Pharmaceuticals and Biotechnology

  • FDA creates expanded access working group (BioCentury)
  • Actavis Ordered to Continue Selling Old Version of Namenda (Press) (AP) (Pharmalot) (NYTimes) (SCRIP-$)
  • NDA Review ‘Program’ On Track, But Is It Still Doomed? (Pink Sheet-$)
  • Senate makes designer steroids a controlled substance (The Hill)
  • Staffing woes hamper FDA (SCRIP-$)
  • FDA Approves Sanofi Pasteur's New Quadrivalent Vaccine Fluzone (Press)
  • Reagan-Udall Foundation Releases Draft Research Agenda for IMEDS (RUF)
  • New FDA Grant: Clinical Studies of Safety and Effectiveness of Orphan Products Research Project (FDA)
  • OGD Continues Tightening BE Requirements for Extended-Release Products (Lachman)
  • FDA: Agency's Tools Not Strong Enough To Stop Brands' Misuse Of REMS (IHP-$)
  • Now That the Foundation Has Been Laid, OGD is Making Moves to Crank Up the Machine (Lachman)
  • FDA advisers support pediatric studies of three investigational oncology agents (Oncology Practice) (Tarius)
  • How Should the FDA Regulate Fecal Transplantation Safely and Effectively? (Harvard BOH)
  • What the AstraZeneca and Ranbaxy Pay-to-Delay Case Didn’t Tell Us (Pharmalot)
  • Pediatric Exclusivity Statistics (FDA)
  • PTO Internal Review Board Upholds First Brand Patent in Generics Challenge (FDAnews-$)
  • Orexo: FDA Approves Two Higher Dosage Strengths of ZUBSOLV (Press)

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

  • Novartis' psoriasis drug tops J&J's Stelara as it speeds toward approval (Fierce) (Reuters)
  • Jazz Pharmaceuticals Initiates Rolling NDA Submission For Defibrotide For The Treatment Of Severe Hepatic Veno-Occlusive Disease (Press)
  • Batu Biologics Submits Investigational New Drug Application for Lung Cancer Anti-Angiogenic Immunotherapy with FDA (Press)
  • Lakewood-Amedex Submits Investigational New Drug Application for Bisphosphocin™ Nu-3 for the Treatment of Diabetic Foot Infections (Press)
  • Million-Person Study Shows No Link Between Pioglitazone and Bladder Cancer (CancerNetwork)
  • Pacira Pharmaceuticals Inc. Announces Changes to EXPAREL Label (Press)
  • Immunovaccine Receives FDA Fast Track Designation for DPX-Survivac for Treatment of Ovarian Cancer (Press)

US: Pharmaceuticals and Biotechnology: General

  • The Cost And Value Of Drugs: Benefits And Effectiveness (Forbes)
  • The Lawsuit Against Gilead's Pricing is Pretty Sparse (WonkBlog)
  • Anecdotal Data Raises Some Concerns About Gilead's Truvada (Reuters)
  • Senate Dem touts millions for painkiller abuse in funding bill (The Hill)

US: Medical Devices

  • FDA medical device head says time to approve trials is getting shorter (BioFlash)
  • FDA Approves Test to Confirm Presence of Human T-cell Lymphotropic Virus-I/II Antibodies (FDA) (Press)
  • Bard Judge Says Implant Maker Facing Billions in Verdicts (Bloomberg)
  • VertiFlex, Inc. Announces FDA Advisory Panel Meeting for the Superion® Interspinous Spacer System (Press)
  • Cianna Medical wins FDA nod for breast surgery device (Mass Device)
  • CenterVue EIDON Receives 510(k) FDA Clearance (MedDeviceOnline)

US: Dietary Supplements

  • Overall FDA's 483 observations are down, but basic GMP failures still rampant (NI-USA)
  • DoJ Aims To ‘Do Something About’ Crime In FDA-Regulated Industries (Tan Sheet-$)
  • Hatch, Harkin Worry FDA Seeks to Apply Food Additive Standards to Supplements (NPI)
  • Payouts begin in massive FTC weight loss settlement (NI-USA)

US: Assorted And Government

  • Review: FY 2014 Inspectional Observation Summaries (FDAatty)
  • Dozens of lawmakers call for liver ‘redistricting’ plan (The Hill)
  • IOM Plans Meeting on Development and Use of Biomarkers for Molecularly Targeted Therapies (IOM)

Upcoming Meetings

Europe

  • Investigation Calls EU Device Approval Standards a "Farce" (RadarTV)
  • Medical Countermeasures That Could Be Procured In Common Under The Joint Procurement Agreement (EC-PDF)
  • Abbott snags CE mark for molecular diagnostic platform for sepsis (Fierce)

India

  • India extends price caps to 52 more essential drugs (Reuters) (India Times)
  • AdvaMed demands separate regulations for medical devices (PharmaBiz)
  • India Working on Bulk Drugs Policy (India Times)
  • Emerging Markets Regulatory Tracker: India (PharmAsia-$)

China

  • China's Health Food Reforms Offer More Proposals than Solutions (Forbes)

Other International

  • ICH Reforming In Ways That Could Strengthen Harmonization Process (Pink Sheet-$)

Clinical Trials

  • Debunking Common Myths About Clinical Trials (PhRMA)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #457 – 11 December 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.

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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