Regulatory Focus™ > News Articles > Regulatory Reconnaissance (3 May 2013)

Regulatory Reconnaissance (3 May 2013)

Posted 03 May 2013 | By Alexander Gaffney, RAC

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

In Focus: US

In Focus: International

  • EC Releases New Template for Declaring Equivalence to EU GMPs (EC)
  • India's DCGI instructs CDSCO zonal offices to constitute expert panels to inspect clinical trials (PharmaBiz)
  • 81% Of China's Generic Drug Applications Are Redundant (PharmAsia News) ($)
  • China's Generic Trade Plagued With Quality, Redundancy, Supply Issues (PharmAsia News) ($)
  • Australia: Consultation: Proposed amendments to the new regulatory framework for In Vitro Diagnostic medical devices (IVDs) (TGA)
  • Cancer drug Avastin tied to 52 cases of flesh-eating disease, 17 deaths (CBC News)

Comments? Suggestions? Shoot me an email at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • Obama: FDA Plan B Decision Leaves Me Feeling 'Very Comfortable'(Huffington Post) (Reuters) (The Hill)
  • Decades-old question: Is Anti-Bacterial Soap Safe? FDA is Finally Looking to Study That Question (AP)
  • FDA panel rejects Aveo's kidney cancer drug tivozanib (Fierce Biotech) (Reuters) (The Street) (Aveo) (PMLive) (SCRIP Intelligence) (The Pharma Letter) (Xconomy) (Med Page Today) (BioCentury) (The Pink Sheet)
  • Generics May Have Tmax Flexibility, FDA Says (The Pink Sheet) ($)
  • False Friends: FDA's "Gift" on NESINA - Present or Poison? It May Depend on Which Hatch-Waxman Language is Spoken (FDA Law Blog)
  • Anacor Pharmaceuticals Provides Update Regarding Arbitration With Valeant Pharmaceuticals (Business Wire)
  • Emergency visits related to sleep drug zolpidem rising (USA Today)
  • Teva submits thrice-weekly Copaxone sNDA (BioCentury)
  • RNL BIO files IND for stem cell product with FDA (BioSpectrum)
  • Gilead combo hepatitis C pill shown effective in small trial (Reuters)
  • Women's health groups slam Obama administration's decision to appeal morning-after pill ruling (CBS) (NPR)
  • Manufacturing issues trip up approval for Gilead, Impax (Fierce Pharma Manufacturing)
  • Hospira ramps up in face of shortages, FDA concerns (Fierce Pharma Manufacturing)
  • Apotex's Planned Angiomax Generic Spurs Patent Suit (Law 360) ($)
  • California Regulators Endorse Senate Track-and-Trace Draft (FDA News) ($)
  • Pharma Cos. Smell Victory In Push For Drug-Tracking System (Law 360) ($)
  • New Staff Manual for CDER's Office of Strategic Program's Office of Program and Strategic Analysis (FDA)
  • Study: Most U.S. Women Want Birth Control Pills To Be Available Over The Counter (Think Progress) (Reuters)
  • FDA Approves Numerous Labeling Revisions for Neurontin (gabapentin) (FDA)
  • American Lifestyle Vicerex and Black Ant Capsules: Recall - Undeclared Drug Ingredient (FDA) (FDA)
  • Public hands in 371 tons of prescription drugs (The Hill)
Medical Devices
Assorted
  • Impact of Sequestration on Life Sciences--FDA Can't Travel (Bloomberg BNA)
  • Sequester Kills a Veterinary Medicine Internship Program on Regulatory Research (FDA)
  • Quarterly FAERS Database Update Released (FDA) (FDA)
  • White House Is Skewered For Putting India On Trade Watch List (Pharmalot)
  • PhRMA "dismay" over US India, Canada trade moves (Pharma Times) (PhRMA)
  • Michael J. Fox Foundation takes first step toward crowdsourced research (Mobi Health News)
Government and Budget
  • Cancer Drug Coverage Parity Act of 2013 (Scout)
Upcoming Meetings and Events
  • 29 April 2013: Accessible Medical Device Labeling in a Standard Content and Format (FDA)
  • 29 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 29 April 2013: Margaret Hamburg to Appear at Milken Institute Conference on 'The Promise of the Bioscience Century' (Milken)
  • 30 April 2013: Meeting of the Risk Communication Advisory Committee (FDA)
  • 2 May 2013: Meeting of the Oncologic Drugs Advisory Committee (FDA)
  • 2 May 2013: Meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee (FDA)
  • 3 May 2013: Joint Meeting of the Medical Imaging Drugs Advisory Committee and Oncologic Drugs Advisory Committee (FDA)
  • 9 May 2013: Senate HELP Committee Hearing on Pharmaceutical Compounding and its Proposed Legislative Solution (Senate)
  • 16 May 2013: OPDP Enfocement Actions Webinar (FDA)
  • Other Upcoming FDA Advisory Committee Meetings and Topics (FDA)

International

  • EC Releases New Template for Qualified Persons to Declare Equivalence to the EU GMP for Investigational Medicinal Products Manufactured in Third Countries (EC)
  • India's DCGI instructs CDSCO zonal offices to constitute expert panels to inspect clinical trials (PharmaBiz)
  • 81% Of China's Generic Drug Applications Are Redundant (PharmAsia News) ($)
  • China's Generic Trade Plagued With Quality, Redundancy, Supply Issues (PharmAsia News) ($)
  • Australia: Consultation: Proposed amendments to the new regulatory framework for In Vitro Diagnostic medical devices (IVDs) (TGA)
  • Cancer drug Avastin tied to 52 cases of flesh-eating disease, 17 deaths (CBC News)
  • Arena withdrawing Belviq MAA (BioCentury) (PMLive) (Reuters)
  • New Zealand's PHARMAC Proposes access widening for ursodeoxycholic acid (PHARMAC)
  • European Medicines Agency welcomes new Head of Infrastructure Services (EMA)

General Regulatory and Interesting Articles

  • Interesting Conference Session on Precision/Personalized Medicine (Milken Institute)
  • New Superbug Strain Found in Scotland (Medical Daily)
  • Big drugmakers think small with nanomedicine deals (Reuters)
  • Glaxo Mined Online Parent Discussion Boards For Vaccine Worries (WSJ) (Med City News)

Regulatory Reconnaissance #59 - 3 May 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.


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