Regulatory Focus™ > News Articles > Regulatory Reconnaissance (16 September 2013)

Regulatory Reconnaissance (16 September 2013)

Posted 16 September 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

Editor's Note: I'm at a regulatory conference all today and tomorrow. Regular coverage will resume on Wednesday, 18 September.

In Focus: US

  • U.S. FDA Posts Import Alert For Ranbaxy's Mohali Site (PharmAsia) (India Times) (Bloomberg)
  • Negotiators Hope To Reach Pact On Bicameral Drug Compounding Proposal By Monday (IHP)
  • Post-Market AEs Emerge with New Antimicrobials (MedPage Today)
  • FDA To Be More Vigilant About Proposed Clinical Trial Exclusions (Pink Sheet)
  • Companion Diagnostics For Breakthrough Drugs Also Getting Swift Attention, FDA Says (Grey Sheet)
  • What The UDI Date Format Says About FDA's Direction (RxTrace)

In Focus: International

  • Japan's PMDA To Roll Out New Safety Infrastructure And Drug Development Support (Pink Sheet)
  • Expert panel on FDC issues draft policy guidelines for approval of FDCs in India (PharmaBiz)
  • India Begins to Regulate the Use of Antibiotics (PharmaBiz)
  • Canada's Health Minister sets out plan to help reduce impact of drug shortages (Pharma Letter)

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

US

Pharmaceuticals/Biotechnology
  • U.S. FDA Posts Import Alert For Ranbaxy's Mohali Site (PharmAsia) (India Times) (Bloomberg)
  • Negotiators Hope To Reach Pact On Bicameral Drug Compounding Proposal By Monday (IHP)
  • Post-Market AEs Emerge with New Antimicrobials (MedPage Today)
  • FDA To Be More Vigilant About Proposed Clinical Trial Exclusions (Pink Sheet)
  • Compressed Breakthrough Therapy Timelines Require Intensified Upfront Sponsor Dialogue on CMC Plans Internally, With Contractors and With FDA (IPQ)
  • Sequester Travel: Halved FDA Budget Limits Opportunities For Scientists, Impacts Senior Officials Too (Pink Sheet)
  • Opioid Post-marketing Studies: Can Sponsors Work Well Together Again? (Pink Sheet)
  • Vioxx Maker Merck Settles False Advertising Suit (MedPage Today)
  • FDA to discuss Gilead's sofosbuvir (BioCentury) (Pink Sheet)
  • FDA Lifts Clinical Hold of Pluristem's Phase II Intermittent Claudication Study (Pluristem)
  • AstraZeneca Can't Block Generic Nexium During Appeal (Law 360) (AZ) (Reuters)
  • GSK receives Priority Review from FDA for dabrafenib/trametinib combination in metastatic melanoma (GSK)
  • Breakthrough status for GSK and Genmab leukaemia drug (Pharma Times) (GSK) (Fierce)
  • Arzerra gets breakthrough designation for first-line CLL (BioCentury)
  • Hospira Recalls Injectable Drug due to 'Presence of Particulate Matter' (FDA) (Hospira)
  • Gay Blood Donors Ban Endures In The U.S., Despite Lacking 'Sound Science' (AP)
  • Court Dismisses Lanham Act-Orange Book Therapeutic Equivalence Rating Complaint on Primary Jurisdiction Grounds (FDA Law Blog)
  • SCRIP US Capitol Capsule (SCRIP)
  • "Not Another Avastin," FDA Panel Warns Genentech At Perjeta Review (Pink Sheet)
  • FDA Approves Generic Azilect for Parkinson's and Generic Navelbine for Lung Cancer (FDA)
  • India's Sun Pharma gets FDA nod for Prevacid generic drug (Reuters)
  • Indian firms get FDA approval for 110 generic drugs so far in 2013 (India Times)
  • Bayer has spent $1.4 billion to settle lawsuits over Yaz (Reuters)
  • Drugs for Inherited Cancers Get Fresh Push (WSJ)
Pharmaceuticals and Biotechnology: General
  • Will Breakthrough Therapies Face Reimbursement Challenges? (Pink Sheet)
  • Antibiotics Go Head-To-Head In PCORI-Funded Observational Study (Pink Sheet)
Medical Devices
  • Companion Diagnostics For Breakthrough Drugs Also Getting Swift Attention, FDA Says (Grey Sheet)
  • What The UDI Date Format Says About FDA's Direction (RxTrace)
  • FDA Awards CDRH Contract to Study Characerization of Abdominal Aortic Aneurysms Under Critical Path Program (FDA)
  • Bard Said to Settle Vaginal-Mesh Case Set for Trial (Bloomerg)
  • August 2013 510(k) Clearances (FDA)
  • Class 1 Recall for Infusion System (FDA)
  • New Study Says Obamacare Will Boost Consumer Medical Device Market To $10 Billion (Forbes)
Assorted And Government
  • Industry Comments Roll in on Draft IDE Clinical Investigations Guidance (FDA)
Upcoming Meetings And Events
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting, no Known Agenda as of Yet (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Summary of the CVMP Meeting (EMA)

Asia

  • Japan's PMDA To Roll Out New Safety Infrastructure And Drug Development Support (Pink Sheet)
  • Expert panel on FDC issues draft policy guidelines for approval of FDCs in India (PharmaBiz)
  • India Begins to Regulate the Use of Antibiotics (PharmaBiz)
  • CDSCO begins joint inspection of blood banks in Kerala (PharmaBiz)
  • Sri Lanka again bans drug imports from Indian firms (BioSpectrum)

Other International

General Regulatory And Interesting Articles

  • Looking for lessons in cancer's 'miracle' responders (Reuters)
  • How Will Wireless Power Change Medical Devices in the Future? (Tech Crunch)
  • Sharp rise in opioid drugs prescribed for non-cancer pain, reports study in Medical Care (EurekAlert)

Regulatory Reconnaissance #155 - 16 September 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