Regulatory Focus™ > News Articles > Regulatory Reconnaissance (31 July 2013)

Regulatory Reconnaissance (31 July 2013)

Posted 31 July 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • FDA Accelerated Approval For Rare Diseases Again Under Congressional Pressure (Pink Sheet)
  • Sunshine Act Data Collection To Begin August 1 (Covington & Burling)
  • FDA guidances on REMS coming by YE14 (BioCentury)
  • Patients Get FDA's Ear, Opening Door To Relaxed Approvals (Law 360)
  • Mounting Opposition To Compounding Bill Plagues Efforts To Advance Legislation Before Recess (IHP)
  • Study: Advertising Makes Drugs Function Better (In the Pipeline)
  • FDA 510(k) 'Refuse To Accept' Policy Audit To Examine Accuracy Of Decisions (IHP)
  • FDA: mHealth pending guidelines not just about 'cool' apps (Gov Health IT)
  • Sen. Durbin Demands Tougher Regulation of Dietary Supplements (USA Today)
  • The FDA is Targeting Social Media (Natural Products Insider)

In Focus: International

  • Fresenius Sacks Indian API Management Staff Over QC Data Cover-Up (In-Pharma Technologist)
  • India's Strides responds to FDA, continues shipments to U.S (Reuters)
  • More China Woes For GSK? CFDA Wades Into Ozanezumab Controversy (PharmAsia)
  • More Bad News For Novartis Blood Pressure Drug (Forbes) (Fierce) (BioSpectrum) (BioSpectrum) (Pink Sheet)
  • Single EU patent court delayed 'until 2016 or beyond' as jurisdiction amended (SCRIP)
  • EU Commission clears way for Bayer acne pill sales in France (Reuters)
  • MHRA appoints three directors to its Board (Pharmafile)
  • BMJ: Sharing data from clinical trials: where we are and what lies ahead (BMJ)

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

US

Pharmaceuticals/Biotechnology
  • FDA Accelerated Approval For Rare Diseases Again Under Congressional Pressure (Pink Sheet)
  • Sunshine Act Data Collection To Begin August 1 (Covington & Burling)
  • FDA guidances on REMS coming by YE14 (BioCentury)
  • Patients Get FDA's Ear, Opening Door To Relaxed Approvals (Law 360)
  • Mounting Opposition To Compounding Bill Plagues Efforts To Advance Legislation Before Recess (IHP)
  • FDA's Draft Guidance For Industry On Pre-Launch Activities Importation Requests: Dead On Arrival? (Life Sciences Law Blog)
  • Study: Advertising Makes Drugs Function Better (In the Pipeline)
  • Are 90% Of FDA Drugs Approved In Last 30 Years No More Effective Than Existing Drugs? (Forbes)
  • FDA and Manufacturers Ponder Biosimilars Pathway (Biopharm International)
  • FDA Approves Lupin's Generic Ranexa (Ranolazine, ANDA #201046) (FDA)
  • Government Wants to License Aresenic Trioxide for Potential Use in Acute Inflammatory Conditions (DHHS)
  • FDA Submits Request to OMB to Extend Life of CGMP Guidance on PET Drugs (OMB)
  • Clinical hold lifted on Cangene's hemophilia FIX (SCRIP)
  • Vanda leaps on tasimelteon Priority Review (BioCentury) (SCRIP)
  • Orphan-drug designation for Nav1.7 blocking pain drug CNV1014802 granted (MNT)
  • Superior Court of Pennsylvania Delivers Quadruple Whammy in Metoclopramide Failure-to-Warn Preemption Decisions; Gives RLD Theory of Liability Some Legs (FDA Law Blog)
  • CBER's Direct Recall Classification Program Webinar: Materials Available (FDA)
Pharmaceuticals: General
  • 'Sunshine-ing' on Docs Signals End to Pharma Largesse (MedPage Today)
  • Consumer Awareness Of New Obesity Drugs Remains Low (Pharmalot)
  • Survey: Drug info is physicians' top use for mobile (Mobi Health News)
Medical Devices
  • FDA 510(k) 'Refuse To Accept' Policy Audit To Examine Accuracy Of Decisions (IHP)
  • FDA: mHealth pending guidelines not just about 'cool' apps (Gov Health IT)
  • Warning Letter to Device Company Cites Failure to Fill out Form 2579 for X-Ray Product (FDA)
  • Sorin Group Announces FDA 510(K) Clearance for the New Sorin CONNECT(TM) Perfusion Charting System (Sorin)
  • Ambio Remote Health Monitoring System Secures FDA 510(k) Clearance (Ambio) (MedGadget)
  • Teleflex Receives FDA Clearance for ARROW GPSCath Balloon Dilatation Catheters in Higher RBP and 80 cm Lengths (Telflex)
Assorted And Government
  • Sen. Durbin Demands Tougher Regulation of Dietary Supplements (USA Today)
  • The FDA is Targeting Social Media (Natural Products Insider)
  • Workshop: Trial Designs and Endpoints for Liver Disease Secondary to Nonalcoholic Steatohepatitis (FDA)
  • FBI launches cyberattack reporting portal for industry (Federal Times)
  • NORD Urges Congress: Don't Cut Orphan Drug Tax Credit (BIO)
  • Dietary Supplements Containing Unsafe Food Additive Destroyed (FDA)
  • Supplement Company Gets Warning Letter for DMAA Products, Citing USPLabs Letter (FDA)
  • Study: REINS Act could save tens of billions in regulatory costs (The Hill)
Upcoming Meetings And Events
  • 25-26 July 2013: Meeting on Standardizing and Evaluating Risk Evaluation and Mitigation Strategies (FDA)
  • 29 July 2013: Workshop on Clinical Development Programs for Opioid Conversion (FDA)
  • 30-31 July 2013: Workshop on Battery-Powered Medical Devices (FDA)
  • 31 July 2013: Nonprescription Drugs Advisory Committee Meeting  (FDA)
  • 2 August 2013: Blood Products Advisory Committee Meeting (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Single EU patent court delayed 'until 2016 or beyond' as jurisdiction amended (SCRIP)
  • EU Commission clears way for Bayer acne pill sales in France (Reuters)
  • MHRA appoints three directors to its Board (Pharmafile)
  • BMJ: Sharing data from clinical trials: where we are and what lies ahead (BMJ)
  • Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) (EMA)
  • £4.8m funding awarded for smart approaches to reduce animal use in science (NC3Rs)
  • Overview of the CE Mark Approval Process for Medical Devices (Emergo)
  • U.K. regulators revive 10-year-old Carestream warning (Mass Device)
  • German HTA Blueprint Could Be Imposed On Greece (Pink Sheet)

Asia

Regulatory Reconnaissance #121  - 31 July 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.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe