Regulatory Focus™ > News Articles > Regulatory Reconnaissance (15 August 2013)

Regulatory Reconnaissance (15 August 2013)

Posted 15 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • FDA's Quest For More MDR Exemption Requests Leaves Device Industry Jittery (Silver Sheet)
  • It's Official: FDA Approval Does Not Equal CMS Coverage (RPM Report)
  • Court's FOIA Ruling Could Endanger Trade Secrets (BioWorld)
  • FDA's Anti-Counterfeit Strategy Gets Advisory Committee Review (Pink Sheet)
  • Forest Laboratories and Almirall Decide to Delay NDA Filing for Aclidinium/formoterol Combination (PR) (PMLive) (Pharma Letter)
  • Evidence Supports Finasteride To Prevent Some Prostate Cancers (NPR) (NPR) (NEJM) (NYTimes)
  • Bayer's riociguat gives FDA new opportunity to shift how it evaluates PAH rugs (BioCentury)
  • How do prescription drugs get such crazy names? (The Week)
  • Compliance Testing Standards: Pitfalls in ISO/IEC 17025 (MDDI)
  • Industry Ties Raise Questions About Expert Medical Panels (NPR) (MedPage Today)

In Focus: International

  • ABPI toolkit to help pharma companies disclose trial data (PMLive) (Pharma Times)
  • The Falsified Medicines Directive: Impacts on API Imports (Reuters)
  • EMA circumspect on India: Trials Difficulty a Concern for Sponsors, not Regulators (BioCentury)
  • EMA Updates dossier-submission requirements for active-substance master files (EMA)
  • Surprise! Roche Says It Will Not Pursue Herceptin Patents In India (PharmAsia)
  • First Diovan Investigational Committee Meeting: New Data Discrepancies In Two More Trials (PharmAsia)
  • China Drugmakers Decline on Corruption Crackdown (Bloomberg) (PMLive)
  • New Brazilian anti-bribery law carries 'severe penalties' for companies (SCRIP)

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

US

Pharmaceuticals/Biotechnology
  • GW and Otsuka pursue US MS indication for cannabis-derived Sativex (SCRIP) (Fierce)
  • FDA's Anti-Counterfeit Strategy Gets Advisory Committee Review (Pink Sheet)
  • New Drug Approved to Help Agriculture's Helpful Honey Bees (FDA)
  • Forest Laboratories and Almirall Decide to Delay NDA Filing for Aclidinium/formoterol Combination (PR) (PMLive) (Pharma Letter)
  • Chelsea responds to FDA; Northera clock to soon tick again (SCRIP)
  • Evidence Supports Finasteride To Prevent Some Prostate Cancers (NPR) (NPR) (NEJM) (NYTimes)
  • FDA Approves Epaned, a Liquid Form of Enalapril for Children and Adults (Silvergate)
  • A Takeda Manager Asks The Supreme Court To Review A Whistleblower Ruling (Pharmalot)
  • OPDP Letters for Promotion of Investigational Compounds, Part 1 (Eye on FDA)
  • Bayer's riociguat gives FDA new opportunity to shift how it evaluates PAH rugs (BioCentury)
  • 483s for Two Amgen Plants (Medical Devices Summit)
  • Advaxis' ADXS-HPV Granted Orphan Drug Designation for Treatment of HPV-Associated Anal Cancer (Advaxis)
  • Nuvo announces Mallinckrodt submits PK study report in response to PENNSAID® 2% FDA complete response letter (Nuvo)
  • Theravance Says Antibiotic is Back on the Market (PharmPro) (SCRIP)
  • Amgen Talks to Buy Onyx Said to Stall on Drug Trial Data (Bloomberg)
  • Medicare changes, not FDA warning, seem to have curtailed use of dialysis drugs (Washington Post)
  • Ampio jumps on Phase III OA data (BioCentury) (SCRIP)
  • Phase III safety and efficacy data of Trajenta® (linagliptin) in elderly people with Type 2 Diabetes published in The Lancet (Boehringer Ingelheim)
  • Families Heartbroken Over Loss Of Experimental Drug (CBS)
  • FDA Approves Stem Cell Clinical Trial For Multiple Sclerosis (PR Newswire)
  • Avanir Settles With Sandoz Over Nuedexta Generic Plans (Law 360)
  • Genentech Resolves Boniva Shortage (FDA)
Pharmaceuticals: General
  • How do prescription drugs get such crazy names? (The Week)
  • Buying Plan B Is Still Confusing (Jezebel)
  • Selling the disease to sell the cure with low testosterone campaign? (MedCity News)
Medical Devices
  • Compliance Testing Standards: Pitfalls in ISO/IEC 17025 (MDDI)
  • FDA's Quest For More MDR Exemption Requests Leaves Device Industry Jittery (Silver Sheet)
  • Bard's fate hangs with jury in latest vaginal mesh lawsuit (Fierce)
  • FDA sticks 'deadly' tag on Nova's glucose test strips (Fierce)
  • Natus Neurology Incorporated Receives 510(k) for its Electrodiagnostic UltraPro S100 EMG System (Natus)
  • Heart Stents Continue to Be Overused (NYTimes)
  • FDA Submits Pediatric Use of Devices Document to OMB (OMB)
Assorted And Government
  • Court's FOIA Ruling Could Endanger Trade Secrets (BioWorld)
  • It's Official: FDA Approval Does Not Equal CMS Coverage (RPM Report)
  • FDASIA Pediatric Provisions Could Be Complicated By Communication, Waivers (IHP)
  • Industry Ties Raise Questions About Expert Medical Panels (NPR) (MedPage Today)
  • FDA's former IT boss nails down industry gig (Fierce)
  • Avoiding FDA 483s Strategy #2: Shore up quality control at release time (FDAzilla)
  • Mandatory, Voluntary Recalls Distress Supplement Firms (Pink Sheet)
  • FDA Enforcement Report - Week of August 14, 2013 (FDA)
  • New FDA Draft Guidance for Medical Foods Suggests that Some Common Products and Certain Label Statements Violate FDA Regulations (FDA Law Blog)
  • App Connects Food Poisoning Victims; Could Connect Class Actions (Food CT)
  • FDA Denied Request To Extend Terrorism Food Contamination Rule (Food Product Design)
  • Charter for the Presidential Advisory Council on HIV/AIDS Renewed (DHHS)
Upcoming Meetings And Events
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • 16 August 2013: Risk Communication Advisory Committee (FDA)
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • ABPI toolkit to help pharma companies disclose trial data (PMLive) (Pharma Times)
  • The Falsified Medicines Directive: Impacts on API Imports (Reuters)
  • EMA circumspect on India: Trials Difficulty a Concern for Sponsors, not Regulators (BioCentury)
  • Workshop on conflicts of interests: deadline for registration extended (EMA) (EMA)
  • EMA Updates dossier-submission requirements for active-substance master files (EMA)
  • UK Says Consumers Will Soon be Able to Purcahse HIV Self-Testing Kits if Products Meet Regulations (UK)
  • GSK's Tyverb approved for use with Herceptin (SCRIP) (GSK)
  • NxThera Announces CE Mark for its Rezum System to Treat Benign Prostatic Hyperplasia (NxThera)

Asia

  • Surprise! Roche Says It Will Not Pursue Herceptin Patents In India (PharmAsia)
  • First Diovan Investigational Committee Meeting: New Data Discrepancies In Two More Trials (PharmAsia)
  • China Drugmakers Decline on Corruption Crackdown (Bloomberg) (PMLive)
  • SciClone Reveals Second Subpoena For China Bribery Allegations (PharmAsia)
  • Astellas' Irribow OD Tablets Approved in Japan for Diarrhea-predominant Irritable Bowel Syndrome (Astellas)

Other International

  • Medicines Patent Pool Is 'Taken Seriously' Now (Pharmalot)
  • Novartis MenB vaccine approved in Australia (Pharma Letter)
  • New Brazilian anti-bribery law carries 'severe penalties' for companies (SCRIP)

General Regulatory And Interesting Articles

  • Full registration and reporting of all trials at PLOS Medicine (PLoS)
  • How Two Guys From Queens Are Changing Drug Discovery (Forbes)
  • A Roomba for Your Vascular System (MedGadget)
  • Vaccination Appears to Have Halted a Meningitis Outbreak (NYTimes)

Regulatory Reconnaissance #132  - 15 August 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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