Regulatory Focus™ > News Articles > Regulatory Recon: Panel Recommends Overturning Gay Blood Ban (14 November 2014)

Regulatory Recon: Panel Recommends Overturning Gay Blood Ban (14 November 2014)

Posted 14 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Panel Recommends Overturning Gay Blood Ban (14 November 2014)

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

In Focus: US

  • Blood Donations by Gay Men Gain Support in U.S. Panel Vote (Bloomberg)
  • Senators to FDA: Get Data on Antibiotics in Food-Producing Livestock (Pharmalot) (Senate)
  • Best Practices for Handling FDA Inspections (PCM)
  • USP Offers New Compounding Compendium; Convenient Access to Quality Standards for Specially Prepared Medicines (USP)
  • Devicemaker faces federal charges for varicose vein treatments (Modern Healthcare)
  • Boston Scientific Hit With $27M Bellwether Mesh Verdict (Law 360-$) (Bloomberg) (Reuters)
  • The Importance of Quality Control Agreements (NPI)

In Focus: International

  • Police search India drug factory linked to sterilization deaths (Reuters)
  • Health Experts: Say No to Randomized Trials Testing Ebola Drugs (Thompson Reuters)
  • Council of EU refuses to be pushed by new European Parliament on medtech regs (Clinica-$)
  • Yes, Doctor, I Took My Anti-HIV Meds (But Really, I Didn't) (NPR)

US: Pharmaceuticals and Biotechnology

  • Blood Donations by Gay Men Gain Support in U.S. Panel Vote (Bloomberg)
  • Senators to FDA: Get Data on Antibiotics in Food-Producing Livestock (Pharmalot) (Senate)
  • Best Practices for Handling FDA Inspections (PCM)
  • USP Offers New Compounding Compendium; Convenient Access to Quality Standards for Specially Prepared Medicines (USP)
  • Pharmaceutical Compounding: Quality standards for different scales (Pew)
  • Jury Clears J&J Unit In Children's Tylenol Suit (Law 360-$)
  • Hamburg: The FDA and Personalized Medicine – Forging a New Era of Progress (FDA)
  • CredibleMeds Awarded Three-Year FDA Contract To Support the Safe Use of Antibiotics (Press)
  • FDA Speaks at Annual HDMA Track-and-Trace Conference (FDA Law Blog)
  • FDA Explains its Approval of the MenB Vaccine Trumenba (FDA)
  • Op-Ed The sham drug idea of the year: 'pink Viagra' (LATimes)
  • FDA Posts Advisory Committee Materials for a Review of the Overall Risk-Benefit of Epidural Steroid Injections (Tarius)
  • FDA Approves Janssen’s Schizoaffective Disorder Treatment (Press)
  • In Connecticut, Medical-Pot Program Draws Mixed Reviews (WSJ-$)
  • Former Ranbaxy execs build NJ startup to help Indian, European drugs enter U.S. market (MedCity News)

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

US: Pharmaceuticals and Biotechnology: General

  • State to promote drug development in space through 'Galactic Grant Competition' (BioFlash)
  • Senate to Investigate High Price of Generic Drugs Next Week (Senate)
  • To the Moon: Will Rising Prices For Some Generic Drugs Never End? (Pharmalot)

US: Medical Devices

  • Devicemaker faces federal charges for varicose vein treatments (Modern Healthcare)
  • Boston Scientific Hit With $27M Bellwether Mesh Verdict (Law 360-$) (Bloomberg) (Reuters)
  • How Registries Provide Insights into Medical Device Outcomes (MDDI)
  • FDA approves 2 new Allergan breast implants (Mass Device)
  • CDC: Lazy Contact Lens Use Main Cause of Eye Infections (AP) (CBS) (NPR)
  • West’s NovaGuard SA Safety System FDA Cleared (MedGadget)

US: Dietary Supplements

  • District Court Enters Permanent Injunction Against California Dietary Supplement Company and Chief Executive Officer to Stop Distribution of Adulterated Products (DOJ)
  • CRN Launches Tool for Regulatory Compliance (NPI)
  • The Importance of Quality Control Agreements (NPI)
  • 20 Years of DSHEA: Focusing on the Future (Nutra Ingredients)
  • Public Notification: Mayhem Contains Hidden Drug Ingredients (FDA)

US: Assorted And Government

  • FDA Updates FOIA Office Contact Information (FDA)

Upcoming Meetings

Ebola Outbreak

  • Health Experts: Say No to Randomized Trials Testing Ebola Drugs (Thompson Reuters)
  • Chimerix antiviral to be tested in West African Ebola trial (Reuters)
  • MSF should have called for Ebola vaccine earlier, says aid group veteran (Reuters)

Europe

  • Review to ask: is NICE fit for purpose? (SCRIP-$)
  • Council of EU refuses to be pushed by new European Parliament on medtech regs (Clinica-$)
  • Device users need more say in EU regulation-making (Clinica-$)
  • ABPI speaks out against changes to UK Cancer Drugs Fund medicines list (PharmaLetter-$) (BioCentury)

India

  • Post-Mortems of Victims Point to Tainted Medication in India Sterilization Deaths (NYTimes)
  • Police search India drug factory linked to sterilization deaths (Reuters)

Australia

  • Cereform breast implants and associated sizers - update - product cancellation (TGA)
  • Problems with submitting some online forms on the TGA website (TGA)

Other International

  • Pfizer and Aid Groups Team Up on Depo-Provera Contraceptive for Developing World (NYTimes) (Reuters)
  • For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "Guidance on Medical Device Quality Management System - Requirements for Distributors" (AHWP)
  • For endorsement at the 19th AHWP Meeting in Seoul - PROPOSED FINAL document on "Adverse Event Reporting Timelines Guidance for Medical Device Manufacturer and its Authorised Representative" (AHWP)

Clinical Trials

  • Yes, Doctor, I Took My Anti-HIV Meds (But Really, I Didn't) (NPR)
  • Trial transparency's impact opaque say drug and CRO industry experts at PCT in Barcelona (Outsourcing Pharma)
  • Data Standards And Technology Empower Life Sciences Companies (Forbes)

General Regulatory And Interesting Articles

  • While I was sleeping: Shopping sprees, sugar binges and other confessions of an Ambien zombie (Today)
  • The Pill’s Difficult Birth (New Yorker)
  • Stop Developing Drugs for the Cancer That Killed My Mother (Nautilus)
  • Arazy Group Launches New Global Regulatory Management System, Regislate (Arazy)

Regulatory Reconnaissance #441 – 14 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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