Regulatory Focus™ > News Articles > Regulatory Reconnaissance (5 November 2013)

Regulatory Reconnaissance (5 November 2013)

Posted 05 November 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • New lung cancer initiative could be model for collaborative drug testing (BioCentury-$)
  • Coalition calls on USP to use risk-based biorelevant analyses in new general chapter (In-Pharma)
  • FDA Forwards Renewed Quality Agenda at ISPE's Annual Meeting (Pharma Manufacturing)
  • Medtronic, Boston Scientific patent fight before Supreme Court today (Fierce)  (Patent Docs)
  • FDA Launches Course to Assist Sponsors with eCopy Submission Compliance (FDA) (FDA)
  • Antibiotic-tainted enzymes find way into supplements in US, Canada, EU and Japan (Nutra Ingredients)
  • Eshoo: user fees must be excluded from sequestration (BioCentury)

In Focus: International

  • EFPIA Calls On Drug Firms To Embrace Multi HTA Early Dialogue Scheme (Pink Sheet-$)
  • EMA, EDQM Set up Meeting on Cell-Based and Gene-Therapy Products (EMA)
  • Germany to stop assessments of pre-AMNOG drugs (BioCentury)
  • Indian regulator upbeat on trials situation but damage done says industry (SCRIP-$)
  • Russia opts for strict approach in evolving regulatory landscape (SCRIP-$)

US: Pharmaceuticals/Biotechnology

  • New lung cancer initiative could be model for collaborative drug testing (BioCentury-$)
  • J&J Whistleblowers to Collect $167.7 Million Under False Claims Act (CNN)
  • Coalition calls on USP to use risk-based biorelevant analyses in new general chapter (In-Pharma)
  • FDA Forwards Renewed Quality Agenda at ISPE's Annual Meeting (Pharma Manufacturing)
  • DEA's Publishes Long-Anticipated Proposed Rulemaking Proposing to Place Tramadol in Schedule IV (FDA Law Blog)
  • Pediatric Advisory Committee Will Preview CDK & PD-1 Inhibitors (Pink Sheet-$)
  • Curemark begins rolling NDA for autism product (BioCentury)
  • Aeterna Zentaris Submits New Drug Application to FDA for Macimorelin Acetate (AEZS-130) for Evaluation of AGHD (Press)
  • Bennet, Burr, Hatch Applaud First FDA Approval of Breakthrough Therapy Drug (Senate)
  • Pfizer Receives FDA Approval for a Prior Approval Supplement for EMBEDA (morphine sulfate and naltrexone hydrochloride) Extended Release Capsules CII (Press)
  • Merck & Co to file new HPV jab this year (Pharma Times) (SCRIP-$)
  • More data for two-dose regimen of GSK's HPV vaccine (BioCentury) (Press)
  • Takeda Triumphs In Suits To Block Generic Dexilant (Law 360-$)
  • DOJ: SAC $1.8bn confession shows no institution 'too big to jail' (SCRIP-$)
  • Teva asks U.S. justices for stay in Copaxone case (Reuters)
  • Shire's ADHD drug succeeds in trial to treat binge eating (Reuters)
  • ImmunoGen, Inc. Announces Discontinuation of IMGN901 Study in Small-Cell Lung Cancer (Press)
  • BD Rx Announces FDA Approval of High-Demand Injectable for Pain Management (Press) (DSN)
  • Orphan status for Stem Cell's leukaemia drug (PMLive)
  • A New Off-Label Use Hot Spot: Abortion (Drug and Device Law)
  • New Animal Drugs; Afoxolaner; Carprofen; Ceftiofur Hydrochloride; Monensin (FDA)

US: Pharmaceuticals and Biotechnology: General

  • US docs hold back patients until new HCV drugs arrive (Pharma Times)

US: Medical Devices

  • Medtronic, Boston Scientific patent fight before Supreme Court today (Fierce)  (Patent Docs)
  • Funding Dries Up for Medical Startups (WSJ-$)
  • FDA Launches Course to Assist Sponsors with eCopy Submission Compliance (FDA) (FDA)
  • Class 1 Recall for Edwards Lifesciences' EMBOL-X Glibe Protection System Dye to Deformed Cannula Tip (FDA) (FDA)
  • Sequenom becomes second casualty of Myriad ruling (EP Vantage)
  • OrSense Receives FDA Clearance for Its Noninvasive Hemoglobin Monitor (Press)
  • Ethicon's ENSEAL Tissue Sealers Gain Expanded Indication for ENT in US (MedGadget)

US: Dietary Supplements

  • Antibiotic-tainted enzymes find way into products in US, Canada, EU and Japan (Nutra Ingredients)

US: Assorted And Government

  • Eshoo: user fees must be excluded from sequestration (BioCentury)
  • Solicitation for Nominations for Membership on the Secretary's Advisory Committee on Human Research Protections (DHHS)
  • Six Members of FDA's Advisory Committees Granted Waivers This Year (FDA)

Upcoming Meetings And Events

  • 4-5 November 2013: Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 5 November 2013: Hamburg Attending Bloomberg Innovation Event (BGov)
  • 8 November 2013: Ear, Nose and Throat Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 13 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 13 November 2013: Vaccines and Related Biological Products Advisory Committee Meeting (FDA)
  • 14 November 2013: Peripheral and Central Nervous System Drugs Advisory Committee Meeting (FDA)
  • 19 November 2013: Endocrinologic and Metabolic Drugs Advisory Committee Meeting (FDA)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • 9 December 2013: Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee (FDA)
  • 11 December 2013: Meeting of the Endocrinologic and Metabolic Drugs Advisory Committee (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EFPIA Calls On Drug Firms To Embrace Multi HTA Early Dialogue Scheme (Pink Sheet-$)
  • Germany's Biotest under investigation over bribery allegations (Reuters)
  • EMA, EDQM Set up Meeting on Cell-Based and Gene-Therapy Products (EMA)
  • Germany to stop assessments of pre-AMNOG drugs (BioCentury)
  • NICE urges pharma: "think creatively" (Pharma Times)
  • Workshop on the clinical investigation of new medicines for the treatment of multiple sclerosis (EMA)
  • New UK drug pricing details expected tomorrow (Pharma Times)
  • Avedro Announces CE Mark Clearance for its KXL II  Advanced Cross-linking System (Press)

Asia

  • Indian regulator upbeat on trials situation but damage done says industry (SCRIP-$)
  • Russia opts for strict approach in evolving regulatory landscape (SCRIP-$)
  • India Releases New Edition Of Drug Pharmacopoeia Covering Changes (PharmAsia-$)
  • PhRMA Appeals To Japanese Government To Abolish 14-Day Prescription Limit (PharmAsia-$)

Other International

  • The Future of Medical Product Approval in South Africa (CATO)

General Regulatory And Interesting Articles

  • Hepatitis C, a Silent Killer, Meets Its Match (NYTimes)
  • Risk Management: An Unlikely Source of Product Innovation? (MDDI)

Regulatory Reconnaissance #195 - 5 November 2013

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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