Regulatory Focus™ > News Articles > Regulatory Reconnaissance (21 March 2013)

Regulatory Reconnaissance (21 March 2013)

Posted 21 March 2013 | By Alexander Gaffney, RAC

Good morning and welcome to another edition of Regulatory Reconnaissance.

In the US, states are ramping up a crackdown on compounding pharmacies, a review panel tepidly approves of Abbott's implantable heart device, FDA is out with a MAPP for its new drug guidance-generating office, a GSK drug gets a new advisory committee date, a company stops a schizophrenia drug trial due to efficacy concerns, a Congressional hearing over device regulation continues, Chinese hackers appear to be targeting drug companies, FDA issues a slew of RPM updates, and energy drinks are looking to un-classify themselves as supplements.

Abroad, EMA is out with a new guidance on chronic primary immune thrombocytopenia, BMJ says new devices should be subject to clinical trials in the EU, the US' GDUFA is causing problems for Indian generic manufacturers, EMA plans a workshop on multiplicity issues in clinical trials, EMA looks to hire a statistician to help review raw drug data, and the UK's new budget is reportedly friends to pharma companies.

Five in Focus:

  1. FDA advisers vote for approval of Abbott's implantable heart device (Reuters) (Med Page Today) (Cardiovascular Business) (Mass Device) (Abbott)
  2. Chinese hackers targeting the healthcare industry (Fierce Health IT)
  3. EU hesitates to follow US approach on medical devices (EurActiv) (BMJ)
  4. FDA Issues Slew of RPM Updates (FDA), MAPP for CDER's New Office of Medical Policy (FDA)
  5. States cracking down on specialty pharmacies (Washington Post)


  • States cracking down on specialty pharmacies (Washington Post)
  • Justices Explore Fine Line on Generic Drug Injuries (NYTimes) (WSJ) (BioCentury) (The Pink Sheet Daily)
  • FDA Releases MAPP for CDER's New Office of Medical Policy (FDA)
  • CDER Office Of Computational Science To Enhance FDA's Data Access (The Pink Sheet Daily) ($)
  • CDER Presentation: Contemporary Issues in Clinical Pharmacology (FDA)
  • CDER Presentation: Clinical Pharmacology and The Turning Tide of Drug Regulation (FDA)
  • Deal in Mass. suit on pregnancy drug (AP)
  • FDA Reschedules Postponed Pulmonary-Allergy Drugs AdComm for 17 April 2013 (GSK's Breo Ellipta) (FDA)
  • BioLineRx stops schizophrenia drug trial, shares plunge (Reuters)
  • Parkinson's Patients May Be Harmed by Novel Treatment (Bloomberg)
  • Sandoz launches generic contraceptives (Drug Store News)
  • DPT Laboratories Receives Close-Out Letter From FDA (Pharma Manufacturing)
  • Protection offered by GSK malaria vaccine fades over time (Reuters)
  • Saluting Dr. Janet Woodcock: an FDA Advocate for Arthritis Sufferers (FDA)
  • Nexgen Pharma Gets ANDA Approval to Market Generic Mecamylamine Hydrochloride for Hypertension (FDA)
  • More Than 400 Innovative Medicines in Development For Top Chronic Diseases Affecting Older Americans (PhRMA)
  • Hyperbolic OTC obesity drug ads backfire (MM&M)
Medical Devices
  • FDA advisers vote for approval of Abbott's implantable heart device (Reuters) (Med Page Today) (Cardiovascular Business) (Mass Device) (Abbott)
  • Day 2: Congressional hearing on FDA regulating apps (Mobi Health News) (Bloomberg) (iHealth Beat) (Congress)
  • FDA Releases List of all PMA's Approved Between 21 September and 28 November 2012 (FDA)
  • January 2013 PMA Approvals (FDA)
  • SynCardia 50cc Total Artificial Heart Wins FDA HUD Designations for Children and Small Adults (MedGadget) (Cardiovascular Business)
  • Ethicon Receives 510(K) Clearance For ENSEAL® G2 Cordless (J&J)
  • Sorin eyes FDA approval with heart device trial (Fierce Medical Devices)
  • If Medical Devices Could Talk to Each Other, It Would Save More Than $30 Billion A Year (MDDI)
  • Class I recall for BleaseFocus Anesthesia Workstations Due to Defect Leadin to Increase in CO2 Concentration (FDA)
  • Class 1 Recall for Guardian II and Guardian II NC Hemostasis Valve Due to Risk of Air Embolism (FDA)
  • Medicrea Receives FDA Pediatric Clearance for PASS LP Systems (Herald Online)
Government and Budget
  • Bill to give Congress veto power over regulations advances in House (The Hill)
  • Senate passes funding bill, shutdown threat dims (Federal Times)
  • Senate to continue 34 hours more of budget debate on Thursday (The Hill)
  • Unified House Republicans poised to pass Ryan budget blueprint (The Hill)
  • Budget Sequestration and the U.S. Health Sector (JAMA)
Meetings This Week
  • March 20, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting Announcement (FDA) (Meeting Materials)
  • March 21, 2013: Meeting of the Psychopharmacologic Drugs Advisory Committee Meeting Announcement (FDA)
  • March 22, 2013: FDA Public Workshop: Innovations in Breast Cancer Drug Development - Neoadjuvant Breast Cancer Workshop (FDA)


  • Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia (EMA)
  • Committee for Orphan Medicinal Products (COMP) meeting report on the review of applications for orphan designation (EMA)
  • BMJ: Trials are needed before new devices are used in routine practice in Europe (BMJ)
  • EU hesitates to follow US approach on medical devices (EurActiv)
  • CellSeed Europe Ltd. withdraws its marketing authorisation application for OraNera (autologous oral mucosal epithelial cells) (EMA)
  • India may provide incentives to generics industry to help deal with GDUFA (PharmaBiz)
  • European Medicines Agency workshop on multiplicity issues in clinical trials (EMA)
  • Report from the European & Developing Countries Clinical Trials Partnership Published (EDCTP)
  • Public consultation of the Draft Project Plan on "Duodenal-jejunal bypass sleeve (Endobarrier) for the treatment of obesity" (EU Net HTA)
  • £80m 'wasted' on smallpox terror threat (The Independent)
  • India Generics Makers Keep Troubled Eye On FTA Negotiations With EU (PharmAsia News) ($)
  • EMA Hiring a Statistician (EMA)
  • Expanded Pfizer accreditation should have "global repercussions" for AAHRPP (Pharma Times)
  • UK Budget 2013: pharma 'pleased' (Pharmafile)

General Regulatory and Interesting Articles

  • Cell Therapy Shows Promise for Acute Type of Leukemia (NYTimes)
  • "Tiny Lab" Implanted Under Skin Transmits Blood Marker Levels (Medical News Today)
  • Biogen's injectable MS drug cut relapse rate by 36 percent (Reuters)
  • Some popular vaginal products linked to infections, study finds (NBC)
  • How vaccine scares cast shadows over science (Reuters)

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 or @AlecGaffney 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.

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