Regulatory Focus™ > News Articles > Regulatory Reconnaissance (8 July 2013)

Regulatory Reconnaissance (8 July 2013)

Posted 08 July 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Today's edition include stories we missed during our two-day holiday on 4-5 July.

In Focus: US

In Focus: International

  • Dr Ian Hudson appointed as the MHRA's new Chief Executive (MHRA) (Clinica) (Pharmafile)
  • EU scrutinizes medtech review "shopping" (Mass Device)
  • MEPs divided ahead of vote on medical devices (EurActiv)
  • ENVI vote on EU IVD reg text also hits two-month delay (Clinica)
  • Upcoming ENVI Meeting to set EMA's User Fees for Pharmacovigilance Activities (ENVI) (ENVI)
  • HMA Checklist: Hope for Drugmakers Struggling with New API Import Regs (In-Pharma Technologist)
  • Drug Technical Advisory Board reccomends no compensation if a drug fails to deliver desired results during clinical trials (India Times)
  • China probes pricing at drugmakers including GSK, Merck (Reuters) (Pharma Letter) (PMLive) (Pharma Times) (FT) (FT) (Fierce)
  • Glaxo Probes Complaint on China Sales of Botox (Bloomberg) (WSJ) (Reuters) (Pharmalot)
  • India's move to modernize its medical device regulations appears close (Fierce)
  • China FDA Urged To Reduce IND Timeline To 30 Days (PharmAsia)

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

US

Pharmaceuticals/Biotechnology
  • FDA Rule to Expose Generic-Drug Makers to Liability (WSJ) (NYTimes) (CBS) (The Hill) (Pharma Letter) (Law 360) (Pharmalot) (Fierce) (Life Science  Law Blawg) (Drug Wonks) (BioCentury) (FDA Law Blog) (Inside Counsel) (MNT) (SCRIP)
  • FDA approves Orexo drug to treat opioid addiction (Reuters) (Orexo) (Pharma Letter) (SCRIP) (Pharma Times) (Fierce) (BioCentury)
  • In an Unusual Move, FDA Denies RLD Designation for an Orange Book Listed Drug (FDA Law Blog)
  • FDA warns on Daiichi Sankyo blood pressure drugs (Reuters) (CardioBrief) (MedPage Today) (FDA) (FDA) (SCRIP)
  • Risk Management Professional Society Would Aim To Improve REMS Performance (Pink Sheet)
  • Generic Rx Shortage Initiative Stuck: Too Few Manufacturers To Pick Up Slack (Pink Sheet)
  • A "Breakthrough" Reality Check: Sponsors Seek FDA Flexibility On Manufacturing, Diagnostics (Pink Sheet)
  • FDA Approves ANDAs for Taro's Gabapentin (#076672), Mylan's Rosuvastatin Calcium (Tentative, #079161), Invagen's Rizatriptan Benzoate (#204339), Natco's Rizatriptan Benzoate (#203478), Aurobindo's Rizatriptan Benzoate (#203062), Apotex's Rizatriptan Benzoate (#202477), Lupin's Gatifloxacin (#202653), Mylan's Riluzole (#203042), Glenmark's Rizatriptan Benzoate (#201914), Watson's Rasagiline Mesylate (#201823), Sun Pharma's Finasteride (#090508), Hetero Lab's Finasteride (#090060), and Actelion's Bosentan (#021290) (FDA)
  • Sandoz Issues Recall of Birth Control Drugs due to Incorrect Placebo (FDA)
  • Parkinson's Drug Pulled for Glass Particles (MedPage Today)
  • Hepatitis B Vaccine Pulled (MedPage Today) (FDA) (Reuters)
  • Breckenridge Announces Approval of Rizatriptan Benzoate ODT (Orally Disintegrating Tablets) (Breckenridge)
  • Fresenius gets warning letter for India plant (Fierce)
  • FDA Floats Broader Pathway For Nicotine Replacement Therapies (Pink Sheet)
  • Woodcock Says Patient Benefit Measures Are Biostatistics' Next Frontier (Pink Sheet)
  • Editorial: Full Disclosure Needed for Clinical Drug Data (NYTimes)
  • Purdue Sues Teva To Block 'Abuse-Proof' OxyContin Generic (Law 360)
  • Achillion's hepatitis drug flap points to HIV challenge  (SCRIP)
  • FDA Grants Genentech's Obinutuzumab (GA101) Priority Review for Previously Untreated Chronic Lymphocytic Leukemia (CLL) (Genentech) (Pharma Letter) (MM&M) (Fierce) (Pharma Times) (Pharmafile) (BioCentury) (Reuters)
  • Form 483 Sent to Medi-Fare Drug and Home Health Center for Compounding (FDA)
  • Impax Laboratories Confirms Patent Challenge Relating to Generic TOVIAZ® 4 mg and 8 mg (Impax)
  • Biogen Idec and Sobi Present New Data from the Phase 3 Study of Their Long-Lasting Hemophilia Factor Candidate ELOCTATE (Biogen Idec)
  • FDA grants orphan status to Activartis' brain cancer immunotherapy (PMLive) (MNT)
  • Alpex Aims To Block Zydus' Generic Obesity Drug (Law 360)
  • Hamburg Speech: Accelerating the Development of Pediatric Drugs for Rare Diseases (FDA)
  • DOJ Probing International Pharmaceutical Manufacturing (Policy and Medicine)
  • FDA Sees Challenge In Distinguishing Lung Cancer Symptoms From Drug Side Effects (Pink Sheet)
  • Novartis' secukinumab demonstrates superiority to rival Enbrel in psoriasis study (Pharma Letter)
  • How Sunscreen Can Burn You (NPR) (FDA)
  • Pharmacokinetic Analysis of Toxicants in Non-Human Primates (FDA)
  • Information Technology Project Management & Requirements Gathering for FDA's Chemical Evaluation and Risk Estimation System (CERES) Support Services (FDA)
  • OMB Extends Use of Abbreviated New Drug Application (ANDA) (OMB)
Pharmaceuticals: General
  • Generic Competition Pushing Down HIV Drug Prices, But Patents Keep Newer Drugs Unaffordable (MNT)
  • Toward Patient-Centered Drug Development in Oncology (NEJM)
Medical Devices
  • House Circulating Discussion Draft Bill to Define FDA's Authority on Digital Health (Gray Sheet)
  • Philips announces FDA clearance for its AlluraClarity interventional X-ray system (Philips) (BioFlash) (Mass Device)
  • BioCentury TV Gets Perspectives on the Myriad Supreme Court Decision (BioCentury TV)
  • Clock ticking on vaginal mesh lawsuits against J&J, others (Fierce)
  • Industry Fights FDA's PMA Proposal For External Defibrillators (Gray Sheet)
  • Hacking: Password risk affects some 300 medical devices, says Homeland Security (Mass Device)
  • New Massachusetts Senator Ed Markey Targeted 'Defective Devices' As House Member (Gray Sheet)
  • Guided Therapeutics Continues to Await Update from FDA on Its PMA Application for LuViva® Advanced Cervical Scan (GT)
  • Protecting Device Innovation: An Interview With Tom Fogarty (Gray Sheet)
  • Stryker sued again over allegedly faulty metal hip implant (Fierce)
  • FDA Device Clearance - Clearly Relevant (Drug and Device Law)
  • US FDA panel weighs blood access device risk reclassification (Clinica)
  • Sales reps' presence tied to heart stent use: study (Baltimore Sun)
  • FDA Sends OMB Information Request on Mammography Facilities (OMB)
Assorted And Government
  • Female inmates sterilized in California prisons without approval (CIR)
  • A Honey Of A Warning Letter, Or 'Yes, The FDA Can Read Spanish' (Pharmalot)
  • FTC Working Paper on Effects of Generic Drug Competition on Pricing During 180-Day Exclusivity (FTC)
  • FDA's Biggest DTC Advertising Study Eyes Online Promotion (Pink Sheet)
  • Cap On Mini-Sentinel Funds Raised To $135 Mil. To Support Powerful Surveillance Resource (Gray Sheet)
  • SCRIP's Weekly Capitol Capsule (SCRIP)
  • DHHS to Regulate Allografts as Organs (DHHS)
  • An Interesting Free Speech Case: Are Journal Articles Protected? (Drug and Device Law)
  • National Biodefense Science Board; Call for Nominees (DHHS)
  • Fostering innovation to protect national health and security (FDA)
  • 3 July 2013 Enforcement Report (FDA)
  • Regulatory: Avoiding willful blindness allegations (Inside Counsel)
  • Regulatory: The dos and don'ts of corporate internal investigations-Part 5 (Inside Counsel)
  • Mission Critical: Under New Regulatory Czar Shelanski, OIRA Must Begin to Affirmatively Help Reinvigorate the Regulatory System (CPR)
  • FDA Sends OMB Information Request on CLIA Waiver Applications (OMB)
  • S.1251 -- Caroline Pryce Walker Conquer Childhood Cancer Reauthorization Act (Senate)
  • S.1247 -- Pediatric, Adolescent, and Young Adult Cancer Survivorship Research and Quality of Life Act of 2013 (Senate)
Upcoming Meetings And Events
  • 10 July 2013: Meeting of the Drug Safety and Risk Management Advisory Committee Meeting Announcement (FDA)
  • 12 July 2013: Public Meeting: Implementation of Drug Supply Chain Provisions of Title VII of FDASIA (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Dr Ian Hudson appointed as the MHRA's new Chief Executive (MHRA) (Clinica) (Pharmafile)
  • EU scrutinizes medtech review "shopping" (Mass Device)
  • MEPs divided ahead of vote on medical devices (EurActiv)
  • ENVI vote on EU IVD reg text also hits two-month delay (Clinica)
  • Upcoming ENVI Meeting to set EMA's User Fees for Pharmacovigilance Activities (ENVI) (ENVI)
  • EU approves Novartis eye drug for new use (Reuters) (SCRIP) (Pharma Letter) (PMLive) (Pharma Times) (Fierce)
  • How to deal with uncertified API imports into the EU (SCRIP)
  • Medicines verification in EU: a cloud with an Azure lining (Securing Industry)
  • EU Pharma Wants API Manufacturing Compliance Waivers As Foreign Shortages Loom (Pink Sheet)
  • HMA Checklist: Hope for Drugmakers Struggling with New API Import Regs (In-Pharma Technologist)
  • EU Court Ruling Makes Orphan Drug Application Route More Attractive (Pink Sheet)
  • EMA updates list of drugs subject to new labeling requirements (BioCentury)
  • Breast cancer drug Afinitor (everolimus) fails to get NICE approval (OnMedica) (Pharma Letter) (Bloomberg)
  • Vision: Retina Implant AG wins E.U. approval for sight-restoring microchip (Mass Device) (Reuters)
  • EUnetHTA-EFPIA Collaboration Announced (EUnetHTA)
  • CorMedix Receives CE Mark for Neutrolin® Catheter Lock Solution (CorMedix)
  • Tighter rules on pharma gifts challenged by manufacturers (Pharmafile) (FT) (PMLive)
  • Registration opens for workshop on Conflicts of Interests (EMA) (EMA)
  • EU gets more clout in vaccine procurement and public health emergencies (SCRIP) (EU) (EC)
  • ENCePP guide on methodological standards in pharmacoepidemiology is revised (EMA) (EMA)
  • EMA Approves Extended Xaluprine Shelf Life (MNT)
  • Counterfeiter told to pay £5.6m (PJOnline)
  • Curative Regenerative Drugs Need NICE Rethink, Key U.K. Committee Says (Pink Sheet)

Asia

  • Drug Technical Advisory Board reccomends no compensation if a drug fails to deliver desired results during clinical trials (India Times)
  • China probes pricing at drugmakers including GSK, Merck (Reuters) (Pharma Letter) (PMLive) (Pharma Times) (FT) (FT) (Fierce)
  • Glaxo Probes Complaint on China Sales of Botox (Bloomberg) (WSJ) (Reuters) (Pharmalot)
  • India's move to modernize its medical device regulations appears close (Fierce)
  • China FDA Urged To Reduce IND Timeline To 30 Days (PharmAsia)
  • Centre to amend D&C Rules to declare NIB for testing blood products, enzymes, hormones (PharmaBiz)
  • MHLW Releases New Vision For Japan's Pharmaceutical Industry (PharmAsia)
  • Industry Reacts to Tough Excipient Regulations in China and Brazil (PharmAsia)
  • Japan's 2012 New Drug Approval Period Shortest Since 2000 (PharmAsia)
  • Rebuilding Ranbaxy - CEO Says Quality Compliance Trumps Achieving Growth Targets (PharmAsia)
  • Ranbaxy Plans Overhaul And May Eliminate Hundreds Of Jobs (Pharmalot)
  • MHLW Approves 11 New Components Including Pertuzumab For HER2-Positive Breast Cancer (PharmAsia)
  • Indian Pharma Market For Some Rides on Laptops, Swiss Watches And Exotic Holidays (PharmAsia)
  • Indian Government mulling ban on sale of TB drugs in open market (India Times)
  • Fearing contamination, Chinese pay more for imported infant goods (Reuters)

Other International

  • Consultations on adoption of European Union guidelines in Australia (TGA)
  • Canada's Rx drug coverage system "unsustainable" (Pharma Times) (Eye for Pharma)
  • 24 ways for improving regenerative medicine regulations (Clinica)
  • Synthes Initiates Recall in Australia for its Dynamic Locking Screws (TGA)
  • Rwanda: a model for fighting falsified medicines? (Securing Industry)
  • Codex Becomes Reference Point for Food Supplement Regulation (Natural Products Insider)

General Regulatory And Interesting Articles

  • Different shapes, colors of generic drugs can be confusing, causing patients to stop taking medications (Reuters)
  • Improvements In Drug Development And Efficiency Likely Following Technological Breakthrough (MNT)
  • Can we create alternatives to animal models for asthma research? (NC3Rs)
  • HIV Drugs Getting Better (MedPage Today)
  • Study: Children given antibiotics in first year were more likely to develop eczema (Reuters)

Regulatory Reconnaissance #102  - 8 July 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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