Regulatory Focus™ > News Articles > Regulatory Reconnaissance (7 August 2013)

Regulatory Reconnaissance (7 August 2013)

Posted 07 August 2013 | By Alexander Gaffney, RAC

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

In Focus: US

  • Bayer hypertension drug riociguat gets unanimous backing from FDA panel (Fierce) (SCRIP) (Reuters) (Med Page Today) (Pharma Letter) (BioCentury) (PMLive) (Pharma Times) (Pink Sheet) (Bayer)
  • Feds Worry Takeda Ruling Could Limit Whistleblower Lawsuits (Pharmalot)
  • FDA REMS Open Public Meeting Explored Need for Flexibility in REMS Programs (Policy and Medicine)
  • Anti-Infective Drugs Advisory Committee Meeting to Discuss Dosing Recommendations in Product Labeling (FDA) (BioCentury)
  • What May Come Of CMS' Proposed Device Regulations (Law 360)
  • Industry Weighs in on FDA Draft Guidance on use of ISO-10993 Standard (FDA)
  • Hospital execs: Med device makers react slowly to security threats (Fierce)
  • Maragret Hamburg Gives Speech on Presence of Caffeine in Dietary Supplements (FDA) (Med Page Today)
  • Ex-InterMune CEO Urges Justices To Review Fraud Conviction (Law 360)

In Focus: International

  • China Revokes Patent On Gilead AIDS Drug Over Pricing (BioWorld) (Pharmalot)
  • Ranbaxy's Facilities are Under Review by India Authorities (India Times) (BioSpectrum)
  • India Reverses Suspension of Avandia (CDSCO)
  • Key CFDA Official Calls For More, Better Drug, Food Testing Capabilities (PharmAsia)
  • WHO Chief Margaret Chan Talks About Regulation and Drug Innovation (WHO)
  • Diane OK means return to French market, as OC safety review continues (SCRIP)
  • TransCelerate's Comparator Network now active (Pharma Times)

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

US

Pharmaceuticals/Biotechnology
  • Bayer hypertension drug riociguat gets unanimous backing from FDA panel (Fierce) (SCRIP) (Reuters) (Med Page Today) (Pharma Letter) (BioCentury) (PMLive) (Pharma Times) (Pink Sheet) (Bayer)
  • Feds Worry Takeda Ruling Could Limit Whistleblower Lawsuits (Pharmalot)
  • FDA REMS Open Public Meeting Explored Need for Flexibility in REMS Programs (Policy and Medicine)
  • Anti-Infective Drugs Advisory Committee Meeting to Discuss Dosing Recommendations in Product Labeling (FDA) (BioCentury)
  • FDA 483 Trend #3: U.S. Inspections Intensify (FDAzilla)
  • Form 483 Sent to Pine Pharmacy of Williamsville, NY (FDA)
  • Form 483 Sent to Beacon Hill Medical Pharmacy (FDA) (Fierce)
  • PhRMA: Tens of Millions of Collected User Fee Dollars Remain Out of FDA's Reach (PhRMA)
  • FDA Submits Document to OMB Requesting Ability to Waive Barcode Rule in Certain Cases (FDA)
  • Novartis: Afinitor shows no survival benefit in liver cancer (Reuters)
  • BioGaia: FDA approves BioGaia's request for orphan drug designation (BioGaia)
  • Ampio's Eye Drug Approval Strategy Dealt Another Credibility Hit (The Street)
  • More Trouble For Vanda's Sleep Disorder Drug (The Street)
Medical Devices
  • What May Come Of CMS' Proposed Device Regulations (Law 360)
  • Industry Weighs in on FDA Draft Guidance on use of ISO-10993 Standard (FDA)
  • Hospital execs: Med device makers react slowly to security threats (Fierce)
  • FDA: Interoperability of Devices is Critical (FDA)
  • July 2013 510(K) Clearances (FDA)
  • Are cancer biomarker tests grossly underused? (Fierce)
  • NIH pushes for biomarker research to catch up with needs of kids (Fierce)
  • Philips announces FDA clearance for its Pinnacle³ Proton treatment planning system (Philips) (MedGadget)
  • Dallen Medical Receives FDA 510(k) Clearance for a Polymer Coated Compressyn Band (Dallen)
  • Alere Connect gets FDA 510(k) clearance for home health hub (Mobi Health News)
Assorted And Government
  • Maragret Hamburg Gives Speech on Presence of Caffeine in Dietary Supplements (FDA) (Med Page Today)
  • Ex-InterMune CEO Urges Justices To Review Fraud Conviction (Law 360)
  • HealthIT Czar Steps Down With Boatload Of Accomplishments; Farewell Letter (Forbes)
Upcoming Meetings And Events
  • 5 August 2013: Webinar: Draft GFI On Expedited Programs For Serious Conditions Drugs And Biologics (FDA)
  • 5 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 6 August 2013: Cardiovascular and Renal Drugs Advisory Committee Meeting (FDA)
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Diane OK means return to French market, as OC safety review continues (SCRIP)
  • GSK announces EU submission seeking additional indication for Votrient as maintenance therapy for advanced ovarian cancer (GSK)
  • IQWiG finds no added benefit proven for Constella in IBS (Pharma Letter)

Asia

  • China Revokes Patent On Gilead AIDS Drug Over Pricing (BioWorld) (Pharmalot)
  • Ranbaxy's Facilities are Under Review by India Authorities (India Times) (BioSpectrum)
  • India Reverses Suspension of Avandia (CDSCO)
  • Key CFDA Official Calls For More, Better Drug, Food Testing Capabilities (PharmAsia)
  • India Drug Pricing Czar Admits "Some Guesses" In Setting Caps (PharmAsia)
  • ASIA BEAT: US faces hurdles as TPP talks intensify (SCRIP)

Other International

  • WHO Chief Margaret Chan Talks About Regulation and Drug Innovation (WHO)
  • New Australian biosimilar guidance takes up WHO naming proposal (SCRIP)
  • Australian govt upsets industry with new price cuts (SCRIP)

General Regulatory And Interesting Articles

  • TransCelerate's Comparator Network now active (Pharma Times)

Regulatory Reconnaissance #126  - 7 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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