Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Faster Drug and Device Approvals (5 August 2014)

Regulatory Recon: FDA's Faster Drug and Device Approvals (5 August 2014)

Posted 05 August 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's Faster Drug and Device Approvals (5 August 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals (Health Affairs) (CBS)
  • PMAs Being Approved Twice as Fast in 2014 (MDDI)
  • FDA plans sea change in regulation of drug manufacturing quality, innovation (BioCentury-$)
  • How DMD Patients Wrote a Draft Guidance for FDA (WSJ-$)
  • When unapproved drugs are the only hope—on Compassionate Use Cases (CNBC)
  • FDA piles misery onto Impax with 2nd Form 483 in a week (Fierce) (SCRIP-$) (483)
  • FDA proposal a huge boost to mHealth innovation (mHealth News)

In Focus: International

  • The UK’s Early Access Scheme: Breakthrough Or Mixed Blessing? (In Vivo-$)
  • New French agency head to prioritize drug/device safety, access to innovation (Clinica-$)
  • European Medicines Agency consults on updates to its policy on access to EudraVigilance (EMA)
  • PTC wins EU approval for its DMD drug as Phase III data pend (Fierce) (Pharma Letter-$) (BioCentury)
  • India Becomes the Latest Country to Probe Pay-to-Delay Deals (Pharmalot)
  • China's GMP drive will reduce API competition, says ScinoPharm (In-Pharma)
  • Blood-thinning drug still safe despite deaths, says Australian watchdog (Guardian)

US: Pharmaceuticals and Biotechnology

  • Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals (Health Affairs) (CBS)
  • FDA plans sea change in regulation of drug manufacturing quality, innovation (BioCentury-$)
  • How DMD Patients Wrote a Draft Guidance for FDA (WSJ-$)
  • When unapproved drugs are the only hope—on Compassionate Use Cases (CNBC)
  • FDA piles misery onto Impax with 2nd Form 483 in a week (Fierce) (SCRIP-$) (483)
  • Mixed Messaging: Tier 2 Abuse-Deterrent Opioid Claim Illusive (Pink Sheet-$)
  • What's Happening With the Drug Supply Chain Security Act? (Porzio)

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

  • FDA Accepts Supplemental New Drug Application for Jakafi (ruxolitinib) and Priority Review Granted (Press)
  • FDA: Ph III needed before Arikayce NDA; Insmed plummets (SCRIP-$)
  • Genoa Pharmaceuticals Receives Orphan-Drug Designation for Pirfenidone in the Inhaled Treatment of Idiopathic Pulmonary Fibrosis (IPF) (Press)
  • Positive interim results reported for Arzerra as maintenance therapy for relapsed CLL (Healio) (SCRIP-$)
  • Hopes build for new Novartis heart failure drug (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Experimental Ebola Treatment Came From California Company (NBC) (Atlantic) (SCRIP-$) (Modern Healthcare)
  • Dr. Kent Brantly, American With Ebola, Got Second Dose of Experimental Cocktail (NBC)
  • Glitch Prompts Temporary Shutdown of Pharma Payment Verification System (ProPublica)

US: Medical Devices

  • PMAs Being Approved Twice as Fast in 2014 (MDDI)
  • FDA proposal a huge boost to mHealth innovation (mHealth News)
  • FDA Often Sees No Data, Speaks No Data, Hears No Data—A Failure to Review Data in a 510(k) (DuVal)
  • SonaCare's Sonablate 450 PMA Going Before FDA AdComm (FDA)
  • Dx industry is cautious, wary and diplomatic in the face of FDA's push to regulate LDTs (Fierce)
  • FDA Approves the SynCardia Total Artificial Heart With SynHall Valves (Press)
  • Eli Lilly Uses Device Safety Team For Risk Management Planning (Silver Sheet-$)
  • TAVI study: Sapien tops CoreValve in AR risk, but is CoreValve safer? (Mass Device)
  • Court defines 'breast implant' in Dow Corning's $2B product liability saga (Mass Device)
  • Cardiac Resynchronization Therapy in Women: US Food and Drug Administration Meta-analysis of Patient-Level Data (PubMed)
  • Physicians weigh in on J&J power morcellator recall (Fierce)

US: Assorted And Government

  • New Batch of FDA Warning Letters Posted (FDA)

Europe

  • The UK’s Early Access Scheme: Breakthrough Or Mixed Blessing? (In Vivo-$)
  • New French agency head to prioritize drug/device safety, access to innovation (Clinica-$)
  • European Medicines Agency consults on updates to its policy on access to EudraVigilance (EMA)
  • PTC wins EU approval for its DMD drug as Phase III data pend (Fierce) (Pharma Letter-$) (BioCentury)
  • AB103 Granted Orphan Medicinal Product Designation in the European Union for the Treatment of Necrotizing Soft Tissue Infections (NSTI) (Press)
  • EU orphan status for Raptor’s cysteamine bitartrate in Huntington's disease (Pharma Letter-$)
  • Transluminal Tech’s velox CD Arterial Closure Device Gets EU Approval (MedGadget)
  • IQWIG rebuffs Novo's Tresiba (BioCentury) (SCRIP-$)
  • IQWiG rejects Tecfidera (BioCentury)

India

  • ISCR notes positive response of regulatory authorities, hopeful of return of business for trials (PharmaBiz)
  • India Becomes the Latest Country to Probe Pay-to-Delay Deals (Pharmalot)
  • Patent Controller to issue revised “draft guidelines for examination of patent applications in field of pharmaceuticals” soon (PharmaBiz)

China

  • China's GMP drive will reduce API competition, says ScinoPharm (In-Pharma)

Japan

  • MHLW Orders Novartis To Improve After Side-Effect Report Delay (PharmAsia-$)
  • Lombard Medical’s Aorfix Receives Regulatory Approval in Japan for Treatment of Abdominal Aortic Aneurysms (Press)

Australia

  • Blood-thinning drug still safe despite deaths, says Australian watchdog (Guardian)

Clinical Trials

  • UCB joins clinical trial data sharing portal (PMLive)

General Regulatory And Interesting Articles

  • BioWar Lab Helping To Develop Treatment For Ebola (Forbes)
  • The revival of Phage Therapy to fight Antimicrobial Resistance – Part I: What are the legal implications? (Harvard BOH)

Regulatory Reconnaissance #372 – 5 August 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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