Regulatory Focus™ > News Articles > Regulatory Reconnaissance (12 June 2013)

Regulatory Reconnaissance (12 June 2013)

Posted 12 June 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Tragedy Claims Life of Clawson Bowman, Noted Regulatory Expert and Former RAPS Board Member (AP) (IBT)
  • Sterility of Antiseptic Skin Prep Products: FDA Hearing Stirs Debate (Infection Control Today)
  • Avandia's real lesson: How to use melange of data in real-world risk management (BioCentury)
  • St. Jude Medical Announces FDA Approval of High-Voltage Devices with New Safety Features (St. Jude) (Mass Device)
  • FDA and the Rise of the Empowered Consumer (SSRN)
  • Can a digital platform for pharma marketers also accelerate clinical trials? (Med City News)
  • Captive Chimpanzees in U.S. May Get Status Bump to Endangered, Possibly Affecting Research (Science Insider) (Scientific American) (NYTimes)

In Focus: International

  • Teva's Packaging Switch Possibly Caused By 'Malicious' Human Interference (In-Pharma Technologist)
  • EU exempts MRI sector from new rules on electromagnetic radiation (Clinica)
  • HTA bodies eager for EMA disclosure of clinical trial data (SCRIP)
  • China's Foreign Drug Approval Fees 30 Times Above Domestic Drugs (PharmAsia News)
  • Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents (Vancouver Sun)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Clawson Bowman, Noted Regulatory Expert and Former RAPS Board Member, Passes Away (AP)
  • Sterility of Antiseptic Skin Prep Products: FDA Hearing Stirs Debate (Infection Control Today)
  • Senators urge swift vote on drug compounding bill (The Hill) (HELP Comm.)
  • Lifting Restrictions of 'Morning After' Pill Has Little Impact for Teva (NYTimes)
  • After all the arguing, what if Teva decides to abandon Plan B One-Step? (Philly Pharma)
  • Avandia's real lesson: How to use melange of data in real-world risk management (BioCentury)
  • FDA Advisory Committee to Review Relistor sNDA for Opioid-Induced Constipation in Patients with Chronic Non-Cancer Pain (Drug Safety Monitor) (BioCentury)
  • Slow Releasing Contraceptive API Led to Janssen's Latest Recall (In-Pharma Technologist)
  • Aussie Contract Pharma Packager Hit with US FDA Warning Letter (Outsourcing Pharma)
  • Finding the Good in GDUFA (Pharma Manufacturing)
  • The Obama Administration's Plan B for Plan B: Compliance, or Defiance? (CPR Blog)
  • In dropping opposition to Plan B, U.S. joins small group of nations (Washington Post)
  • Matheson Reintroduces Bill to Combat Drug-Resistant Bacteria (Matheson) (House)
  • Sagent Pharmaceuticals Initiates a Nationwide Recall of Three Lots of Vecuronium Bromide Due to Elevated Impurity Levels (FDA) (FDA)
  • FDA Approves ANDAs for Allied Pharma's Clarithromycin (#202710), Mutual Pharm's Clopidogrel Bisulfate (#078133), and Sun Pharma's Niacin (Tentative, #200484) (FDA)
  • The Post-Yervoy Landscape (BioCentury)
  • Tivozanib "Complete Response" Shows Increased Communications Can't Always Save An NDA (Pink Sheet)
  • CLAAD urges FDA to implement Obama administration's policy on safer opioid medications (News Medical)
  • OTC Morning-After Pill Sales Coming - But Not Yet (AP)
  • FDA's Approval Letter to Sanofi for its Fluzone Quadrivalent (FDA) (FDA)
  • Walgreens pays $80M over prescription negligence (The Hill) (NYTimes)
  • Bethel Nutritional Consulting, Inc. Issues a Voluntary Recall of Weight Loss Pills "Bethel 30" Found to Contain an Undeclared Drug Ingredient (FDA)
  • Road lengthens for Dynavax hep B vaccine Heplisav (SCRIP)
  • A Delay In Relief From Copays For Costly Drugs (NPR)
Medical Devices
  • Q&A: ACLA President Alan Mertz Discusses Citizen Petition Against FDA Regulation of LDTs (GenomeWeb)
  • AngioScore Announces PMA Supplement Approval Allowing a Summary of the AGILITY Coronary Bifurcation Trial Results in the AngioSculpt IFU (AngioScore)
  • FDA Updates List of PMA Summaries (FDA)
  • Meeting Materials Posted for the 13 June Meeting of the Microbiology Devices Panel (FDA)
  • Cook's Zilver stent recall could be a costly one (Fierce)
  • EndoChoice nabs 510(k) for its Fuse colonoscopy system (Mass Device)
  • St. Jude Medical Announces FDA Approval of High-Voltage Devices with New Safety Features (St. Jude) (Mass Device)
  • Blue Belt touts FDA win for Stride knee implant (Mass Device)
Assorted and Government
  • FDA and the Rise of the Empowered Consumer (SSRN)
  • Can a digital platform for pharma marketers also accelerate clinical trials? (Med City News)
  • Captive Chimpanzees in U.S. May Get Status Bump to Endangered, Possibly Affecting Research (Science Insider) (Scientific American) (NYTimes)
  • New FDA Warning Letters Posted (FDA)
  • Q&A for FDA Assistant Commissioner for International Programs Ball (US Embassy)
  • Reagan-Udall Foundation for the FDA Appoints Steering Committee for Innovation in Medical Evidence Development and Surveillance Program (RUF)
  • Lifesaving protections vanishing down regulatory 'rabbit hole,' study says (The Hill) (Washington Post)
  • Opponents of new regs finding ally in White House office, report finds (The Hill)
  • Groups square off over chemical reform bill (The Hill)
  • Human Genome Project Spurred $966 Billion Sciences Boom (Bloomberg)
Upcoming Meetings and Events
  • 11-12 June 2013: FDA/NIH/NSF Workshop on Computer Models and Validation for Medical Devices (FDA)
  • 12-13 June 2013: 16th Annual FDA-OCRA Educational Conference (OCRA)
  • 13 June 2013: 510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device (FDA)
  • 13 June 2013: Good Manufacturing Practice Deficiencies: Federal Health Care Enforcers' Next False Claims Act Target? (WLF)
  • 13 June 2013: Microbiology Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA)
  • 13 June 2013: Markup of FDA Appropriations Bill (House)
  • 14 June 2013: Public Meeting on HIV Patient-Focused Drug Development and HIV Cure Research (FDA)
  • 14 June 2013: Congressional Hearing on Prescription Drug Abuse (E&C)
  • 17 June 2013: FDA Basics Webinar: Biological Products: Part 1 (FDA)
  • 18 June 2013: Understanding the Regulatory Landscape for Adaptive Design Trials (RAPS)
  • 19-20 June 2013: Regulatory Education for Industry (REdI) Conference (FDA)
  • 25-26 June 2013: Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 June 2013: Clinical Development Programs for Opioid Conversion (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

Europe

  • Teva's Packaging Switch Possibly Caused By 'Malicious' Human Interference (In-Pharma Technologist)
  • EU exempts MRI sector from new rules on electromagnetic radiation (Clinica)
  • EU Data Protection Amendments Could Make Medical Research Impossible, Professors Say (Oursourcing Pharma)
  • European Medicines Agency and EUnetHTA review progress of their cooperation (EMA) (EUnetHTA)
  • HTA bodies eager for EMA disclosure of clinical trial data (SCRIP)
  • NICE yes for Novartis eye drug Jetrea (Pharma Times) (Reuters) (SCRIP) (Pharma Letter) (SCRIP)
  • UK's NICE gives thumbs up for GSK's Revolade as NHS blood disorder treatment (Pharma Letter)
  • Turkish pharma "needs inspection deal with EU" (Pharma Times)
  • EMA Recruiting for Several New Positions (EurParl)
  • French "sunshine act" sheds little light on drug industry's payments to doctors, say critics (BMJ)
  • EU seeks group lawsuit rules amid 'litigation culture' fears (EurActiv)
  • Scotland likes Almirall's Constella but not Alimera's Iluvien or Vertex' Kalydeco (SCRIP)
  • ABPI demands more data from NHS (Pharma Times) (Pharmafile)

Asia

  • China's Foreign Drug Approval Fees 30 Times Above Domestic Drugs (PharmAsia News)
  • India Issues Marketing Ban on Dextropropoxyphene (Times of India)
  • All talk? India free drugs plan in doubt (SCRIP)
  • Health ministry yet to take any concrete step on banning Analgin (PharmaBiz)

Other International

  • Yaz and Yasmin birth control pills linked to 23 deaths, say Health Canada documents (Vancouver Sun)
  • WTO TRIPS resolution excludes pharma from IP extension exemption for least-developed countries (Pharma Letter)
  • Collaborative Innovation between CDISC and IMI Facilitates Development of Global Standards (CDISC)

General Regulatory and Interesting Articles

  • Restrictive drug laws censor science, researchers say (Reuters)
  • Amphetamines, Atomoxetine and the Risk of Serious Cardiovascular Events in Adults (Brookings)
  • Stem Cells Reach Standard For Use In Drug Development (MNT)

Regulatory Reconnaissance #86 - 12 June 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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