Regulatory Focus™ > News Articles > Regulatory Reconnaissance (20 September 2013)

Regulatory Reconnaissance (20 September 2013)

Posted 20 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

  • UDI Rule out Today. Stay Tuned to Focus for Coverage
  • Biosimilars should carry same generic names as branded biologics, GPhA says  (FDA Law Blog) (DSN) (BioCentury) (PMLive)
  • CDRH To Beef Up Monitoring Of Device Ads and Promotions (Grey Sheet)
  • Mostashari: FDA should issue mobile health guidance sooner, not later, for clarity's sake (Mobi Health News)
  • FDA's PREDICT Import Screening System Working As Predicted (Pink Sheet)
  • What Makes a "Breakthrough" Therapy? FDA Says More Details Are Coming (RPM Report)

In Focus: International

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

US: Pharmaceuticals/Biotechnology

  • Biosimilars should carry same generic names as branded biologics, GPhA says  (FDA Law Blog) (DSN) (BioCentury) (PMLive)
  • FDA's PREDICT Import Screening System Working As Predicted (Pink Sheet)
  • What Makes a "Breakthrough" Therapy? FDA Says More Details Are Coming (RPM Report)
  • Sanofi in $40 million settlement over obesity drug linked to suicidal thoughts (Reuters) (Law 360)
  • An Overview of the Design and Implementation of FDA's Prospective Routine Observational Monitoring Program Tools for Safety Surveillance (Brookings)
  • ProPublic to Release Investigation Showing FDA, J&J Failed to Act on Tylenol Safety Concerns (ProPublica)
  • PCORI names Norquist chair (BioCentury)
  • Muscular dystrophy drug from GlaxoSmithKline, Prosensa fails PhIII (GSK) (Fierce)
  • Viralytics' melanoma virotherapy hits PhII endpoint early (SCRIP)
  • Lupin gets FDA nod to make generic insomnia drug  (BioSpectrum)
  • ACT Files Investigational New Animal Drug (INAD) Application with FDA to Treat 10 Different Disease Indications Using Pluripotent Stem Cells (ACT) (BioFlash)
  • Survey: Are US authorities holding more drug excipients at ports? (In-Pharma)
  • 'I'm A Poster Child For Compassionate Use:' Andrea Sloan Explains (Pharmalot)

US: Pharmaceuticals and Biotechnology: General

  • New flu vaccines offer extra protection - and more profits (Reuters)
  • Purdue hands California list of risky OxyContin prescribers (Fierce) (Fierce)
  • Elite Army units to stop taking anti-malarial drug (CBS) (Pharmalot)
  • GSK wins $196m US BARDA contract for anthrax antitoxin raxibacumab (SCRIP) (BioCentury)
  • BIO's Sandi Dennis passes away (BioCentury)

US: Medical Devices

  • CDRH To Beef Up Monitoring Of Device Ads and Promotions (Grey Sheet)
  • Mostashari: FDA should issue mobile health guidance sooner, not later, for clarity's sake (Mobi Health News)
  • Will FDA Finally Make the Call on Mobile Medical Apps? (MDDI)
  • FDA eye experts give mixed recommendation for post-op sealant (Ocular) (Mass Device)
  • Edwards hit with shareholder suit over 'misleading' Sapien claims (Fierce)
  • Boston Scientific warns on battery issues in certain implantable defibrillators (Mass Device)
  • Whistleblowers accuse Masimo of concealing evidence (Mass Device)
  • CogCubed Diagnoses ADHD with Video Games (MDDI)
  • Baxter Initiates Voluntary Recall of Two Lots of Dual Luer Lock Caps (FDA)
  • Sapheon Submits First Module of PMA Application for VenaSeal Sapheon Closure System (Sapheon)
  • Crosstrees Medical Receives FDA 510(k) Clearance for Next Generation Device for Percutaneous Vertebral Augmentation (PVA) (Crosstrees)

US: Assorted And Government

  • 4 Ways To Make Sure Comments On Agency Rules Count (Law 360)
  • FTC Concerned About Increase in "Sponsored Content" (PharmExec)
  • Dems launch food labeling overhaul (The Hill)
  • Enforcement Report - Week of September 18, 2013 (FDA)
  • Nominations to the Report on Carcinogens (NTP)
  • Payers Slow to Use Comparative Research Data (MedPage Today)

Upcoming Meetings And Events

  • 18-19 September 2013: The Patient Preference Initiative: Incorporating Patient Preference Information into the Medical Device Regulatory Processes (FDA)
  • 19 September 2013: Ophthalmic Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 19-20 September 2013: Pediatric Advisory Committee Meeting  (FDA) (FDA)
  • 19-20 September 2013: Meeting on Proposed Foreign Supplier Verification Programs (FDA)
  • 24 September 2013: Public Meeting on Narcolepsy Patient-Focused Drug Development (FDA)
  • 25-26 September 2013: ENVI Meeting on Medical Device Proposals (ENVI)
  • 25-26 September 2013: FDA Small Business Regulatory Education for Industry Conference (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • European agency recommends Novo hemophilia drug for approval (Reuters) Positive CHMP opinion for Novo Nordisk's NovoEight (Pharma Letter)
  • Positive CHMP recommendation for Relvar Ellipta (Pharma Letter) (Reuters) (BioCentury) (GSK) (Pharma Times)
  • Fluenz Tetra, four-strain nasal spray vaccine, receives positive opinion in EU from CHMP for the prevention of seasonal influenza in children (AZ)
  • ENVI vote delay: tensions over involvement of EMA (Clinica)

Asia

  • Japan Announces Series of Drug Approvals for Western Firms (Pharma Letter) (GSK) (PMLive) (Pharma Times) (BioSpectrum) (Reuters) (SCRIP)
  • Unlike FDA, Indian regulators finds no violations at Ranbaxy  (BioSpectrum)
  • High Court relief for J&J, can restart production at Mulund factory (India Times)
  • Indian Panel Seeks "Robust" Clinical Regulatory System To Fix Flaws (PharmAsia)
  • US: Drug safety, compliance is top challenge in Asia (BioSpectrum)
  • Should OTC drugs be advertised in Russia? (Pharma Letter)
  • Merck Halts Two Indian Firms From Launching Januvia Copies As It Awaits Crucial Patent Decision (PharmAsia)
  • Otsuka and Lundbeck Receive Positive CHMP Opinion in Europe for Abilify MaintenaTM, a Once-Monthly Injectable for Schizophrenia (PR)
  • Orexo announces the approval of Abstral in Japan (Orexo)
  • Once-Daily Dual Bronchodilator Ultibro Inhalation Capsules (QVA149) Approved for the Treatment of COPD in Japan (Sosei)
  • India gives 114 kids the wrong vaccine in polio mix-up (Fierce)

Other International

  • New WHO prequalification charges could scare off generics companies (SCRIP)
  • OECD countries address the safety of manufactured nanomaterials (OECD)
  • DePuy hip implant class action lawsuits spread north of the border (Mass Device)

General Regulatory And Interesting Articles

  • Are obese people with cancer getting chemotherapy doses too small for them? (CBS)
  • Statins Linked to Cataracts (MedPage Today)
  • 'Bacterial autopsies' can speed up antibiotic discovery say US scientists (Outsourcing Pharma)

Regulatory Reconnaissance #159 - 20 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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