Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Blood Donation Policy Incoherent for Transgender Persons (22 January 2015)

Regulatory Recon: FDA's Blood Donation Policy Incoherent for Transgender Persons (22 January 2015)

Posted 22 January 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA's Blood Donation Policy Incoherent for Transgender Persons (22 January 2015)

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

In Focus: US

  • FDA’s New Blood Donation Guidelines Offer Little Clarity For Transgender People (BuzzFeed)
  • Supreme Court Declines to Review Case About Generic Labeling (Pharmalot) (BioCentury)
  • Novartis' Cosentyx Gets FDA Nod for Psoriasis (MedPage Today) (FDA) (Pink Sheet-$) (Press) (WSJ-$) (Reuters) (BioCentury) (SCRIP-$)
  • What’s Wrong with OGD Workload Reporting? (Lachman)
  • FDA Says Finalizing Opioid Guide A Priority, But Doesn't Commit To Congress' Deadline (IHP-$)
  • Deadly bacteria on medical scopes trigger infections (USA Today)
  • FDA Warns About Safety of Bone Graft Substitutes (FDA) (MPR) (FDA)
  • FDA's Eased Oversight Is Good Omen For Health IT (Law 360-$)
  • 10 Things You Should Know About The Medical Device Single-Audit Pilot (Gray Sheet-$)

In Focus: International

  • EU ADR App To Underpin Region’s Regulatory Approach To Social Media (Pink Sheet-$)
  • New EMA guide on new safety reporting standards (Pharma Times)  (EMA)
  • EMA supply interuption rules need clarification says industry; NGO says high prices cause shortages (In-Pharma)
  • Paediatric guidance revised to reflect changes to European Commission guideline (EMA)
  • A Deep Dive Into How Gilead Lost its Patent on Sovaldi in India (Lexology)
  • Industry Raises Concerns Over Proposed Drug Label Changes in Australia (FDAnews-$)

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US: Pharmaceuticals and Biotechnology

  • FDA’s New Blood Donation Guidelines Offer Little Clarity For Transgender People (BuzzFeed)
  • Supreme Court Declines to Review Case About Generic Labeling (Pharmalot) (BioCentury)
  • Novartis' Cosentyx Gets FDA Nod for Psoriasis (MedPage Today) (FDA) (Pink Sheet-$) (Press) (WSJ-$) (Reuters) (BioCentury) (SCRIP-$)
  • What’s Wrong with OGD Workload Reporting? (Lachman)
  • Biosimilar mAbs may have tougher time winning US FDA approval says expert (BioPharma Reporter)
  • District Court Tackles Sticky 505(b)(2) Application Issues in an Extensive Memorandum Opinion Involving Colchicine (FDA Law Blog) (Pink Sheet-$)
  • Review of Warning and Untitled Letters for 2014 (Eye on FDA)
  • FDA Says Finalizing Opioid Guide A Priority, But Doesn't Commit To Congress' Deadline (IHP-$)
  • Selected FDA Activities on Opioids (Throckmorton)
  • Counterfeit Versions of Cialis tablets identified entering the United States (FDA) (Reuters) (Fierce)

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

  • FDA grants fast track status for Celator's leukemia drug CPX-351 (Press)
  • Study: GSK's malaria vaccine may not be effective when used with bed nets (Fierce)
  • Phase 2/3 Study Data Announced for Vectibix in Colorectal Cancer (MPR)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • Deadly bacteria on medical scopes trigger infections (USA Today)
  • FDA Warns About Safety of Bone Graft Substitutes (FDA) (MPR) (FDA)
  • FDA's Eased Oversight Is Good Omen For Health IT (Law 360-$)
  • 10 Things You Should Know About The Medical Device Single-Audit Pilot (Gray Sheet-$)
  • 5 Things Every QA/RA Professional Should Keep An Eye On In 2015 (Silver Sheet-$)
  • J&J settles the score with over 100 vaginal mesh plaintiffs (Fierce)
  • How FDA Regulates Veterinary Devices (FDA)
  • Bausch + Lomb Introduces New Optical Software (Press)
  • K2M's MESA 2 Deformity Spinal System receives FDA 510(k) clearance Featured (Press)
  • BioStructures, LLC Receives FDA Clearance for Silhouette Mineralized Collagen Scaffold (Press)
  • Summit Medical, Inc. Obtains Two More FDA Clearances (Press)

US: Dietary Supplements

  • 2014 FDA Dietary Supplement Warning Letters Infographic (DSE)
  • Medical foods for blood sugar management in limbo more than a year after FDA issued draft guidance (NI-USA)
  • Clean Bill Of Health For BPA In Europe As FDA Examination Continues (Tan Sheet-$)
  • New York: Supplement Labeling Bill Introduced (Scout)
  • European Food Safety Authority Reports Caffeine Findings (FPD)
  • Seven children may have been taken from their ‘prepper’ parents over dangerous ‘miracle’ supplement MMS (Washington Post)

US: Assorted And Government

  • FDA Looking for New Voting Members for its Science Board (FDA)
  • POGO to FDA: Disclose AdComm Conflicts of Interest (POGO)

Upcoming Meetings

Europe

  • EU ADR App To Underpin Region’s Regulatory Approach To Social Media (Pink Sheet-$)
  • New EMA guide on new safety reporting standards (Pharma Times)  (EMA)
  • EMA supply interuption rules need clarification says industry; NGO says high prices cause shortages (In-Pharma)
  • Paediatric guidance revised to reflect changes to European Commission guideline (EMA)
  • EC Grants Marketing Authorization for Genzyme's Gaucher Drug Cerdelga (Press) (PharmaTimes)
  • European regulators begin review of AZ gout drug (PharmaTimes) (Press)
  • MHRA and HRA welcome public consultation on application of transparency rules of EU Clinical Trial Regulation (MHRA)
  • France Suspends Products Made by Device Manufacturer (ANSM)
  • NICE Recommends BI's Diabetes Drug Jardiance (Press)
  • Opto Circuits' Eurocor wins CE Mark for drug-eluting stent (MassDevice)
  • UK Court: Pfizer Unit Can't Force Actavis To Alter Generic Drug Label (Law 360-$)
  • A Critical Look at the Saatchi Medical Innovation Bill (OpenDemocracy)

India

  • A Deep Dive Into How Gilead Lost its Patent on Sovaldi in India (Lexology)
  • U.S. Supreme Court ruling on Copaxone may flow to India CL cases (Fierce)
  • Indian Pharmacopoeia Commission Preparing New Monographs (PharmaBiz)

Australia

  • Industry Raises Concerns Over Proposed Drug Label Changes in Australia (FDAnews-$)
  • TGA Groups and Offices now called Divisions and Branches (TGA) (TGA)

Regulatory Reconnaissance #477 – 22 January 2015

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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