Regulatory Focus™ > News Articles > Regulatory Reconnaissance (13 September 2013)

Regulatory Reconnaissance (13 September 2013)

Posted 13 September 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Tips? Gripes? Let me know: news@raps.org.

In Focus: US

In Focus: International

  • EU medical devices directives revision: "The wings are not on fire" (Medical Devices Legal)
  • Upcoming ENVI Workshop to Address Effectiveness of Medicines and Therapies (ENVI)
  • Euro Parliament backs biopiracy protocol (PMLive)
  • Analysis: Indian pharma draws more FDA scrutiny as U.S. imports rise (Reuters)
  • Beneath Noise Of Indian Drug Regulatory Reforms Is Weak ADR Reporting Infrastructure (PharmAsia)
  • ANVISA Unveils Ambitious Overhaul Plans for Medical Device Regulations (Mass Device)

Comments? Suggestions? Email me at news@raps.org.

US

Pharmaceuticals/Biotechnology
  • FDA Panel Backs Perjeta as Breast Cancer Neoadjuvant (MedPage Today) (NYTimes) (Reuters) (Pharma Times) (PMLive) (Genentech) (Pink Sheet) (BioCentury)
  • New Recalls by Johnson & Johnson Raise Concern About Quality Control Improvements (NYTimes)
  • FDA rejects Delcath's cancer therapy, asks for more trials (Reuters)
  • Breakthrough designation Q&A (Fierce)
  • FDA CV Requirements Sideline Sanofi's Lixisenatide (Pink Sheet) (SCRIP)
  • GPhA heralds FDA hiring milestone (DSN)
  • Hospira Awaits US Biosimilar Market as EC Approves Inflectra (BioPharma Reporter)
  • Ceftazidime/avibactam Combination Receives Qualified Infectious Disease Product (QIDP) Designation from FDA (Forest)
  • Synta Announces Fast Track Designation Granted for Ganetespib in Non-Small Cell Lung Adenocarcinoma (Synta)
  • Positive Clinical Results for Veentrus Biosciences' Anal Fissures Drug (DD&D)
  • Drug Shortages Continue As Manufacturing Quality Problems Persist (IHP)
  • FTC Wants Access To Boehringer Docs In Pay-For-Delay Probe (Law 360)
  • GSK's Lovaza faces generics after court invalidates Pronova patent (SCRIP) (Pharmalot) (Fierce)
Pharmaceuticals and Biotechnology: General
  • Advocates Try To Pressure NIH To Respond To Norvir Petition (Pharmalot)
  • GlaxoSmithKline's great, terrible, wonderful, not-so-good year (Fierce)
  • What's wrong with big pharma's image? Pfizer CEO says it's an issue of trust (MedCity News)
  • Actavis Launches Generic Version of Opana ER (PharmPro)
  • Wistar receives $1.5 million Department of Defense grant to ready prostate drug for clinical use (EurekAlert)
  • Off-Label Use of Ketamine Increases in Bid to Fight Depression (Scientific American)
Medical Devices
  • Premature Enforcement of CDRH's Draft Cybersecurity Guidance (FDA Law Blog)
  • Ex-CDRH Compliance Leaders And Regulatory Experts Offer Tips For Surviving Face-To-Face Meeting With FDA (Silver Sheet)
  • FDA panel recommends reducing regulatory burden on cardiac devices (Mass Device)
  • Diabetes Tech Society Gets FDA Buy-In For Glucose Monitor Surveillance Program (Gray Sheet)
  • Document And Record Retention: Quick Pointers From FDA And Industry Experts (Silver Sheet)
  • Government, industry and crossed wires (MedDevice Daily)
Assorted And Government
  • GSK's CMO: Unlocking Access to Clinical Trial Data - What Are We Afraid of? (Huffington Post)
  • Government shutdown inches closer as GOP leaders delay vote in House (The Hill)
  • Not In Our Backyard! Pharmacists and Trade Groups Sue to Block Implementation of Maine Drug Importation Law (FDA Law Blog)
  • HHS to Delay Enforcement and Provide Guidance on HIPAA/HITECH Act Final Rule on the Heels of Adheris Lawsuit (FDA Law Blog) (Law 360)
  • Up To 77 Percent Of Viagra Bought Online May Be Fake, And Possibly Dangerous, Research Shows (Forbes)
  • FTC Sends Refund Checks to Consumers Who Bought Dietary Supplements (FTC)
  • New Technologies - Drugs, Devices, and Biotech - Biggest Cause of Medicare Spending Growth (TIE)
Upcoming Meetings And Events
  • 16 September 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • 18 September 2013: ENVI Meeting, no Known Agenda as of Yet (ENVI)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EU medical devices directives revision: "The wings are not on fire" (Medical Devices Legal)
  • Raptor's Procysbi approved for rare disease in EU (Pharma Times)
  • Upcoming ENVI Workshop to Address Effectiveness of Medicines and Therapies (ENVI)
  • Euro Parliament backs biopiracy protocol (PMLive)
  • Gilead Obtains Orphan Designation for Idelalisib (EMA)
  • GlycoMimetics Announces EMA's Granting of Orphan Drug Status in European Union for GMI-1070 in Sickle Cell Disease (GM)
  • Larode Receives Orphan Designation for Octreotide Acetate for Acromegaly (EMA)
  • Richardson Associates Regulatory Affairs Wins Orphan Drug Designation for Esteosarcome Drug (EMA)
  • DFINE, Inc. Receives CE Mark Approval for STAR™ Tumor Ablation System (DFINE)

Asia

  • Analysis: Indian pharma draws more FDA scrutiny as U.S. imports rise (Reuters)
  • Beneath Noise Of Indian Drug Regulatory Reforms Is Weak ADR Reporting Infrastructure (PharmAsia)
  • Japan as No 1: PMDA lays out its regulatory ambitions (SCRIP)
  • Chinese authorities probing German drugmaker Bayer (Reuters) (Pharma Times)
  • ANVISA Unveils Ambitious Overhaul Plans for Medical Device Regulations (Mass Device)
  • Pakistan Drug Makers Say Government Policy Hurting Exports (PharmAsia)
  • India's ISCR concerned over intention of DCGI's order on furnishing payment details to investigators by trial sponsors (PharmaBiz)
  • Panel proposes sweeping changes to India's drug regulatory system (SCRIP)
  • Chinese Pharmacopeia Second Supplement Effective December (PharmAsia)
  • Vietnam evicts substandard imported drugs  (BioSpectrum)
  • Alexion's Soliris® (eculizumab) Receives Marketing Approval in Japan for All Patients with aHUS (Alexion)
  • India's Pharma Industry Hammered by Economic Slowdown (Economic Times)

Other International

  • US FDA Foreign Inspections On the Rise (MDDI)
  • Australia Publicizes its Position on Regulation of Medical Software and Medical "Apps" (TGA)
  • Eli Lilly Levels $500M Attack On Canadian Patent Law (Law 360)

General Regulatory And Interesting Articles

  • Unique Device Identification (UDI): From compliance to competitive advantage (Mass Device)
  • Merck and J&J back StartX; "clinical-trial-in-a-dish" biotech wows (MedCity News)
  • Searching for consensus on the most humane ways to kill laboratory animals (NC3R)
  • Remember the Side Effects of Needed Drugs that Go Untaken (MedPage Today)
  • Vaccine cures HIV-like virus in monkeys (CBS)
  • Meningitis cases fall 94% following vaccine introduction (Fierce)

Regulatory Reconnaissance #153 - 13 September 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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