Regulatory Focus™ > News Articles > Regulatory Recon: Is FDA's Ban on Gay Blood Donors on the Verge of Being Overturned? (12 November 20

Regulatory Recon: Is FDA's Ban on Gay Blood Donors on the Verge of Being Overturned? (12 November 2014)

Posted 13 November 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Is FDA's Ban on Gay Blood Donors on the Verge of Being Overturned? (12 November 2014)

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

In Focus: US

  • Blood Donations by Gay Men Seen Winning U.S. Panel’s Backing (Bloomberg)
  • FDA's Hamburg on Balancing the Risks, Benefits for 310M Patients (Medscape)
  • FDA's post-approval studies continue to suffer delays and setbacks (Nature)
  • Without Enforcement Discretion, Track And Trace Deadlines Could Mean Rx Shortages (Pink Sheet-$)
  • Michigan Bill Looks to Ban Sale of Most Products Containing Triclosan (Bill)
  • Toxic levels of a chemical in plastic medical devices could endanger preemies (WaPo)
  • Becton Dickinson ordered to notify customers about false-advertising claims for safety syringes (Fierce)
  • FDA's Gutierrez clarifies LDT review timelines (BioCentury)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • Blood Donations by Gay Men Seen Winning U.S. Panel’s Backing (Bloomberg)
  • FDA's Hamburg on Balancing the Risks, Benefits for 310M Patients (Medscape)
  • FDA's post-approval studies continue to suffer delays and setbacks (Nature)
  • Without Enforcement Discretion, Track And Trace Deadlines Could Mean Rx Shortages (Pink Sheet-$)
  • Michigan Bill Looks to Ban Sale of Most Products Containing Triclosan (Bill)
  • Therapeutic focus – Survival benefit still eludes ovarian cancer trials (EP Vantage)
  • Doubling Down On Antibiotic Incentives: Congress, Obama Administration Drafting Proposals (RPM Report-$)
  • FDA Advisory Committee to Review Cerexa’s Ceftazidime-avibactam for Complicated Infections (Tarius)
  • FDA Advisory Committee to Review Three Investigational Cancer Drugs For Pediatric Written Requests (Tarius)
  • FDA Issues Warning Letters for Unapproved Omeprazole Drugs Marketed for Use in Horses (FDA)
  • Should FDA Permit the Importation of Drugs by Individuals? (The Hill)
  • U.S. FDA Approves Supplemental New Drug Applications for Once-Monthly Long-Acting Therapy INVEGA SUSTENNA (paliperidone palmitate) for the Treatment of Schizoaffective Disorder (Press)
  • Biothera Names Carey Anderson VP of Regulatory Affairs (Press)

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

  • Humira is in the Crosshairs as Amgen gets its First Phase III Biosimilars Win (Reuters)
  • Merck Braces for Study on Medicines Worth $4 Billion a Year (Bloomberg) (Reuters)
  • FDA and EMA Grant Orphan Designation to Xeris Pharmaceuticals' Soluble Glucagon for Prevention of Hypoglycemia in Congenital Hyperinsulinism Patients (Press)
  • U.S. gene study raises hope for Merck cholesterol drug Zetia (Reuters)
  • Harvoni achieves 81-98% cure rates in hardest-to-treat patients (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Why Are There So Few New Drugs Invented Today? (NYTimes)
  • Pharma Trade Group Head Causes a Stir With a Remark About Patents (Pharmalot)
  • The Short-Term And Long-Term Outlook Of Drug Coupons (Health Affairs)
  • DOJ's Investigation Into Generic Pharma Pricing Is Unusual (Law 360-$)
  • Why some generic drug prices are skyrocketing (CBS) (NEJM)
  • Missouri lawmakers form panel to investigate AG Ties to Pfizer (KMBC)
  • The NFL's Anti-Weed Policy Even Extends to Drugs That Could Prevent Brain Damage (VICE)

US: Medical Devices

  • Toxic levels of a chemical in plastic medical devices could endanger preemies (WaPo)
  • Becton Dickinson ordered to notify customers about false-advertising claims for safety syringes (Fierce)
  • FDA's Gutierrez clarifies LDT review timelines (BioCentury)
  • MasterControl Continues Role as QMS Provider for FDA’s Office of Regulatory Affairs (Press)
  • QSIT At 15: Two Co-Creators Of FDA’s Aging Audit Technique Look Back – And Mull Over Today’s Agency Approach (Silver Sheet-$)
  • Records: Essure birth control maker, Conceptus, cited for malfunctioning, not reporting complaints (NewsNet5)
  • FDA Approves New Styles of Allergan’s NATRELLE 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Press)
  • Roche Receives FDA Clearance for Strep A Test on cobas Liat System (Press)
  • October 2014 510(k) Clearances (FDA)
  • ImThera to begin U.S. testing of sleep apnea device (Mass Device)

US: Dietary Supplements

  • FTC Actions On Supplement Claim Substantiation Put Industry On Alert (Tan Sheet-$)
  • The Scary, Synthetic, and All-Too-Secret Ingredients of Dietary Supplements (National Geographic)

US: Assorted And Government

  • Dassault Systèmes Signs Research Agreement with the Food and Drug Administration for its “Living Heart Project” (Press)

Upcoming Meetings

Europe

India

  • Tainted drugs suspected in Indian sterilization surgery deaths (Reuters)
  • Indian Device Industry Association Works to Build Trust in Devices (PharmaBiz)

Other International

  • WHO's Clinical Trial Data Disclosure Statement Still Open for Comment (WHO)
  • Ukraine plans to ban drug imports from Russia (PharmaLetter-$)

Clinical Trials

  • Therapeutic focus – Survival benefit still eludes ovarian cancer trials (EP Vantage)
  • Medical Science Has a Data Problem (Newsweek)
  • OHRP and Standard-of-Care Research (NEJM)

General Regulatory And Interesting Articles

  • How 3D printing could revolutionize burn treatment (CBS)
  • Near-Animal, Near-Human: The Future of Drug Testing? (In The Pipeline)
  • QT Prolongation Risk Assessed for Non-SSRI Antidepressants (MPR)

Regulatory Reconnaissance #440 – 13 November 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.


Categories: Recon, Regulatory News

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