Regulatory Focus™ > News Articles > Regulatory Recon: FDA Panel Meeting Over Gay Blood Ban Today (2 December 2014)

Regulatory Recon: FDA Panel Meeting Over Gay Blood Ban Today (2 December 2014)

Posted 02 December 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Panel Meeting Over Gay Blood Ban Today (2 December 2014)

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

In Focus: US

  • FDA AdComm Meets Today Over Gay Blood Donor Ban (Tarius) (Webcast)
  • FDA drug tracing regs start Jan. 1, health group asks for leniency (The Hill)
  • Track and Trace: Existing Exchange System Gets Temporary Reprieve (Pink Sheet-$)
  • New Interview with FDA on Key Stem Cell Regulatory Issues & Its Own Research (IPScell)
  • FDA clears Sanofi TB drug indication (Pharmafile) (Reuters) (Press)
  • FDA approves Animas insulin pump, continuous glucose monitor combo device (Fierce)
  • AHA to FDA: Hold med device makers responsible for cybersecurity (Fierce)
  • Label Defects Top List of Packaging Concerns for Med Devices (Medical Design)
  • Changes Coming to Kidney Transplant Waiting List (AP)

In Focus: International

  • MHRA says it will review plans for new UK pharma plants free of charge (In-Pharma)
  • NICE's Nod To Soliris Tainted By Request For R&D Cost Data (Pink Sheet-$) (BioCentury)
  • DNA-screening test 23andMe launches in UK after US ban (Guardian) (BBC) (GenomeWeb)
  • EMA's New Excipient Labeling Drafts (EMA) (EMA)
  • Italy's pharmaceutical watchdog ends alarm on flu drug (Reuters) (Pharmalot) (Fierce)
  • India mulling plan for free essential drugs to all (India Times)
  • India plans to make quality accreditation mandatory for new clinical trials (India Times)
  • Opinion: penalties for error in the proposed Drugs and Cosmetics Bill are extremely unreasonable (Hindu Business Line)

US: Pharmaceuticals and Biotechnology

  • FDA AdComm Meets Today Over Gay Blood Donor Ban (Tarius) (Webcast)
  • FDA drug tracing regs start Jan. 1, health group asks for leniency (The Hill)
  • Track and Trace: Existing Exchange System Gets Temporary Reprieve (Pink Sheet-$)
  • New Interview with FDA on Key Stem Cell Regulatory Issues & Its Own Research (IPScell)
  • FDA clears Sanofi TB drug indication (Pharmafile) (Reuters) (Press)
  • FDA Delays Ruling on Teva Petition Against Generic Copaxone for MS (MS News Today) (FDAnews-$) (SCRIP-$)
  • Gardasil Adverse Events May Be Driven By Birth Control Use (Pink Sheet-$)
  • FDA Updates MAPP on Emergency INDs (King & Spalding)
  • FDA Touts PEPFAR Approvals on World Aids Day (FDA)
  • Group: Shouldn't a Priority Review Voucher Mean a Drug is Affordable and Accessible? (DNDI) (PharmaTimes)
  • SPARC sent complete response letter from FDA for Latanoprost (Business Standard) (India Times)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • New Drug Application for IRESSA accepted by US Food and Drug Administration (Press) (PharmaTimes)
  • US breakthrough status for Takeda drug in amyloidosis (PharmaTimes) (SCRIP-$) (Fierce)
  • Synageva BioPharma Completes Rolling Submission Of Biologics License Application To The FDA For Sebelipase Alfa (Press)
  • FDA accepts priority review for EYLEA injection to treat diabetic retinopathy in DME patients (Press)
  • Bayer to seek approval for haemophilia drug this month (Reuters)
  • Pozen Says Yosprala On Track For Approval Despite Losing Sanofi As Partner (Pink Sheet-$)
  • FDA lifts clinical hold on Flexion's lead drug (Reuters) (BioCentury-$)
  • Lung Therapeutics, Inc. Receives FDA Orphan Drug Designation for Lead Drug Candidate LTI-01 (Press)

US: Pharmaceuticals and Biotechnology: General

  • A new entrant in the battle over drug prices: Hospital systems (TIE)
  • This drug costs $84,000 (And there’s nothing the US health-care system can do to stop it) (Vox)

US: Medical Devices

  • FDA approves Animas insulin pump, continuous glucose monitor combo device (Fierce)
  • AHA to FDA: Hold med device makers responsible for cybersecurity (Fierce)
  • Label Defects Top List of Packaging Concerns for Med Devices (Medical Design)
  • New Emergency Use Authorization for RealStar Ebola Virus Detection Device (FDA)
  • AACC Urges the FDA to Balance the Need for Scientific Oversight of Laboratory Developed Tests With Safeguarding Patient Access to These Essential Tests (Press) (Statement)
  • UnitedHealth rebuffs Cologuard (BioCentury)
  • Power Morcellators are the Latest Hot Target Among Trial Lawyers  (Pharmalot)
  • Thoratec On Track For Late 2015 HeartMate III Launch (Gray Sheet-$)
  • Canon Inc. is Developing a Color Display for Mammography (Press)
  • Cepheid wins FDA nod for norovirus test (Fierce)
  • Siemens Device Recalled; Rapid Gram Negative Combo Panel Can Produce Incorrect Results (FDA)
  • LG receives FDA clearance, likely for a mobile health app (MobiHealthNews)
  • SuperSonic Imagine Receives FDA 510k Clearance for New Musculoskeletal and Vascular Ultrasound Probes (Press)
  • Paragonix Technologies Inc., Announces Clearance of Two 510(k) Premarket Notifications by the US Food and Drug Administration (Press)
  • Luna 360 Interbody Fusion System from Benvenue Medical Receives FDA Clearance for Symptomatic Degenerative Disc Disease (Press)
  • Apex Device to Stop Bladder Leakage Receives FDA Clearance for Sale Over-the-Counter, without a Prescription--Eliminating the Need for Pads for Women Nationwide (Press)

US: Assorted And Government

  • Changes Coming to Kidney Transplant Waiting List (AP)
  • New FDA Guidances for November 2014 (CATO)
  • FDA Weekly Enforcement Report (FDA)

Upcoming Meetings

Ebola Outbreak

  • No serious side effects in Merck/Newlink Ebola vaccine test (Reuters)
  • Obama to tout progress on Ebola vaccine at NIH (The Hill)

Europe

  • MHRA says it will review plans for new UK pharma plants free of charge (In-Pharma)
  • NICE's Nod To Soliris Tainted By Request For R&D Cost Data (Pink Sheet-$) (BioCentury)
  • DNA-screening test 23andMe launches in UK after US ban (Guardian) (BBC) (GenomeWeb)
  • EMA's New Excipient Labeling Drafts (EMA) (EMA)
  • Italy's pharmaceutical watchdog ends alarm on flu drug (Reuters) (Pharmalot) (Fierce)
  • EU medicines agency probes issue with Novartis flu vaccine (Reuters)
  • Unannounced notified body audits to hit 5,000 a year (Clinica-$)
  • Optimism about EU reg adoption timing but scrutiny procedure still bringing headwinds (Clinica-$)
  • NICE u-turn on Roche leukaemia drug (PharmaTimes) (Reuters) (Pharmafile) (SCRIP-$) (BioCentury)
  • All material and documents from the HTA 2.0 Europe conference is now available (EUnetHTA)
  • XTANDI (enzalutamide) Now Approved in Europe for the Treatment of Men with Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve (Press)
  • Application Submitted To The EMA To Expand The Therapeutic Indication For IMBRUVICA (ibrutinib) To Include Treatment Of Waldenström's Macroglobulinemia (Press)
  • pSivida Reports ILUVIEN Granted Marketing Authorization in the Netherlands (Press)
  • Actelion submits new PAH drug in Europe (PharmaTimes) (RTT)
  • Synageva BioPharma Submits Marketing Authorization Application To European Medicines Agency for Sebelipase Alfa (Press)
  • European Medicines Agency Validates Marketing Authorization Application for Natpar (parathyroid hormone (rDNA)) in Hypoparathyroidism (Press)

India

  • India mulling plan for free essential drugs to all (India Times)
  • India plans to make quality accreditation mandatory for new clinical trials (India Times)
  • Opinion: penalties for error in the proposed Drugs and Cosmetics Bill are extremely unreasonable (Hindu Business Line)
  • NPPA asks cos to submit compliance report to prove validity of prior price approval for launch of 'new drug' (PharmaBiz)
  • EPIRUS Biopharmaceuticals Remicade Biosimilar, Infimab, Launches in India (Press)

China

  • BMS Downsizes In China Amid Slow Sales, Regulatory Uncertainty (PharmAsia-$)
  • Regulators meet in Beijing to balance local with global (SCRIP-$)

Canada

  • PrEP approval in Canada stuck in limbo (DailyXtra)
  • Nova Scotia health units warn about 10,000 faulty blood tests (CBC)

Australia

  • Australia Proposes New Labeling Statements on Nexium (TGA)
  • How Does TGA's Adverse Event Reporting System Work? Find Out Here (TGA)

Other International

  • Counterfeits Posing Serious Threat To Turkish Public Health (PharmAsia-$)

General Regulatory And Interesting Articles

  • ​The Salk polio vaccine: A medical miracle turns 60 (CBS)
  • Standard Cardiac Arrest Drug May Not Be Helpful (Forbes)
  • Know the Jargon: Plantibody (Scientific American)

Regulatory Reconnaissance #450 – 2 December 2014

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


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