Regulatory Focus™ > News Articles > Regulatory Reconnaissance (18 October 2013)

Regulatory Reconnaissance (18 October 2013)

Posted 18 October 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Does the FDA Regulatory Process Destroy Business Value? (GEN)
  • FDA's House Rules on 505(b)(2) NDA Choice of Listed Drug; How Does it Affect Dealer's Choice? (FDA Law Blog)
  • FDA issues tissue erosion warning on St. Jude's Amplatzer cardiac implant (Mass Device) (FDA) (FDA) (Cardiovascular Business)
  • Shutdown ends, FDA user fees begin (Mass Device)
  • FDA panel mixed on proposed changes to antibiotic breakpoints (BioCentury) (IHP-$)
  • Ariad Forced to Shutter Vital Study of Iclusig Due to Toxicity (Press) (The Street) (In the Pipeline) (Fierce)
  • FDA Food Center Could Face Backlog, Delayed FSMA Rules Following Shutdown (IHP-$)

In Focus: International

  • Notified bodies dropping like flies? New-style authority audits cause near-50% cull (Clinica-$)
  • Astellas wins NICE backing for Xtandi in prostate cancer (PMLive) (Pharma Times) (SCRIP-$) (Pharma Letter-$) (BioCentury) (Reuters)
  • Badly run trials behind Indian drug testing freeze (New Scientist)
  • CFDA Drafts New Regulations From Results Of Nationwide Fake Drug Crackdown (PharmAsia-$)
  • Chinese regulators considering new clinical trial, adverse event reporting requirements (Mass Device)

US: Pharmaceuticals/Biotechnology

  • FDA's House Rules on 505(b)(2) NDA Choice of Listed Drug; How Does it Affect Dealer's Choice? (FDA Law Blog)
  • US FDA delays sNDA verdict for AMAG's Feraheme, but shares rise  (BioFlash) (Pink Sheet-$) (SCRIP-$) (BioCentury)
  • Ariad Forced to Shutter Vital Study of Iclusig Due to Toxicity (Press) (The Street) (In the Pipeline) (Fierce)
  • FDA panel mixed on proposed changes to antibiotic breakpoints (BioCentury) (IHP-$)
  • Pradaxa Topped FDA Side Effect Reports (Pharmalot)
  • DAs Sue Novartis Over Eyedrop Packaging (Pharmalot)
  • Alimera, pSivida Eye Drug Rejected by FDA (Press) (The Street) (Reuters)
  • Why The FDA Is Right To Block Amarin's Push To Market Fish Oil To Millions (Forbes)
  • Wites & Kapetan, P.A. Investigates Filing Class Action Lawsuit Against ARIAD Pharmaceuticals (Press)
  • Dynavax pursues Heplisav approval with new safety study (SCRIP-$)
  • Nephron Pharmaceuticals Corporation Announces Voluntary Recall of Albuterol Sulfate Inhalation Solution, 0.083% (FDA) (FDA)
  • Cimzia (Certolizumab Pegol) Approved by FDA for Treatment of Adults with Active Ankylosing Spondylitis (Press) (PharmPro)
  • Pfizer Reports Mixed Results on Two Phase III Studies Involving Lyrica (Press)
  • MiMedx to meet with FDA on 28 October (Press)
  • Jubilant receives USFDA approval for two generic drugs (India Times)
  • How Many Inspections has ORA Conducted in Each Country? (FDA)
  • FDA Posts Helpful Resource on Investigator-Initiated INDs (FDA)
  • Cirrus studies formulation effects on MDI performance for US FDA (In-Pharma)
  • GSK waiting to ramp up malaria vaccine manufacturing despite Ph III progress (BioPharma Reporter)
  • US and French regulators OK restart of LentiVector delivered eye drug trials (In-Pharma)

US: Pharmaceuticals and Biotechnology: General

  • Why Express Scripts Tossed 48 Drugs Off Its Formulary (Pharmalot)
  • Study shows swift move from brand to generic drugs (MM&M)
  • Prescription drug use among Medicare patients highly inconsistent (EurekAlert)

US: Medical Devices

  • FDA issues tissue erosion warning on St. Jude's Amplatzer cardiac implant (Mass Device) (FDA) (FDA) (Cardiovascular Business)
  • Shutdown ends, FDA user fees begin (Mass Device)
  • Boston Scientific to pay $30 million over heart devices: U.S. Justice (Reuters)
  • Regulator Orders Becton, Rival To Tone Down Device Claims (Law 360-$)
  • Emergency allergy needles too short for heavy people? (Reuters)
  • EMD Serono Receives FDA Approval for Redesigned Fertility Pen (Press)

US: Dietary Supplements

  • FDA Food Center Could Face Backlog, Delayed FSMA Rules Following Shutdown (IHP-$)
  • Craze manufacturer disputes NSF's discovery of drug tainting (Nutra Ingredients)
  • FDA must find regulatory balance for probiotics says Univ. of Md. law prof (EurekAlert)
  • FTC: Disclosure-Free Claims Could Solve Digital Dilemmas (Tan Sheet-$)

US: Assorted And Government

  • Does the FDA Regulatory Process Destroy Business Value? (GEN)
  • The Shutdown Is Over: What Now for Regulation? (CEI)
  • Decades Later, Condemnation for a Skid Row Cancer Study (NYTimes)
  • OIRA's Budget Hasn't Kept up With Spending by Other Agencies (Mercatus)

Upcoming Meetings And Events

  • 17-18 October 2013: Anti-Infective Drugs Advisory Committee Meeting (FDA) (Day 2)
  • 22-23 October 2013: Cellular, Tissue and Gene Therapies Advisory Committee Meeting (FDA) (POSTPONED)
  • 24-25 October 2013: Antiviral Drugs Advisory Commitee Meeting (FDA) (Day 2)
  • 2-3 December 2013: AHWP/RAPS Joint Conference in Malasia (RAPS)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Notified bodies dropping like flies? New-style authority audits cause near-50% cull (Clinica-$)
  • Astellas wins NICE backing for Xtandi in prostate cancer (PMLive) (Pharma Times) (SCRIP-$) (Pharma Letter-$) (BioCentury) (Reuters)
  • UK NICE raises benchmark on hip implants (Clinica-$)
  • Germany's G-BA confirms benefits of ThromboGenics' Jetrea for VMT (Pharma Letter-$) (BioCentury)
  • G-BA says additional benefit for Bosulif 'unquantifiable' (BioCentury)
  • New once-daily Striverdi (olodaterol) Respimat gains approval in first EU countries (Boehringer)
  • EUnetHTA strengthens its position as the scientific and technical cooperation on HTA in Europe (EUnetHTA)

Asia

  • Badly run trials behind Indian drug testing freeze (New Scientist)
  • CFDA Drafts New Regulations From Results Of Nationwide Fake Drug Crackdown (PharmAsia-$)
  • Chinese regulators considering new clinical trial, adverse event reporting requirements (Mass Device)
  • Barcode procedures for Indian pharma companies simplified (India Times)
  • U.S. FDA Not Only Regulation Pressure Point For India Drug Makers (PharmAsia-$)

Other International

  • Health activists in South Africa urge govt to "stop blindly handing out" pharma patents (Pharma Letter-$)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #181 - 18 October 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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