Regulatory Focus™ > News Articles > Regulatory Reconnaissance (14 August 2013)

Regulatory Reconnaissance (14 August 2013)

Posted 14 August 2013 | By Alexander Gaffney, RAC 

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

In Focus: US

  • FDA Accused by Eisai Of Cutting Obesity Drug's Exclusivity Short (Law 360) (SCRIP)
  • Eyeing Antibiotics, Drugmakers Ask For Longer Pathogen List (Law 360)
  • Eli Lilly's troubled Erbitux successor scores a win in PhIII lung cancer trial (Fierce) (Eli Lilly) (IBJ) (Forbes) (Reuters) (Pharma Times) (PMLive) (Pink Sheet) (BioCentury) (Pharma Letter) (SCRIP) (Bloomberg)
  • Generic Companies Gain Little From FDA Decision On Access To REMS Drugs (Pink Sheet)
  • Actavis' Bioequivalence Data Still Missing For Bupropion XL (Pink Sheet)
  • Merck to study industry use of cattle drug Zilmax (Reuters) (Reuters)
  • FDA cites LumiQuick Diagnostics for marketing Dx tools without approval (Fierce)
  • Gray Zone Between FDA And FTC Nutraceutical Regulation (Law 360)
  • Ex-Herbalife employee subpoenaed over 2011 safety concern: NYT (Reuters) (NYTimes)
  • FDA Plan Falls Short In Tailoring Information To Patient Subgroups, Advocate Says (IHP)

In Focus: International

  • South Africa seeking mutual recognition with FDA and EMA (Drug Wonks)
  • WHO getting ready to unveil norms on prequalification of finished pharmaceuticals (PharmaBiz)
  • U.K. to launch center for personalized medicine diagnostics (BioCentury)
  • MHRA register of in-house tests needed, says UK diagnostics industry (Clinica)
  • Novartis tops list of EU products under "additional monitoring" (SCRIP)
  • China FDA Highlights Product Recalls, Manufacturers Urged To Make Rapid Responses (PharmAsia)
  • China to launch fresh pharmaceutical bribery probe: Xinhua (Reuters)

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

US

Pharmaceuticals/Biotechnology
  • FDA Accused by Eisai Of Cutting Obesity Drug's Exclusivity Short (Law 360) (SCRIP)
  • Eyeing Antibiotics, Drugmakers Ask For Longer Pathogen List (Law 360)
  • Eli Lilly's troubled Erbitux successor scores a win in PhIII lung cancer trial (Fierce) (Eli Lilly) (IBJ) (Forbes) (Reuters) (Pharma Times) (PMLive) (Pink Sheet) (BioCentury) (Pharma Letter) (SCRIP) (Bloomberg)
  • Generic Companies Gain Little From FDA Decision On Access To REMS Drugs (Pink Sheet)
  • Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics; Public Workshop (FDA)
  • Unmet Patient Needs as the Focus of a New Regulatory Pathway (Brookings)
  • Actavis' Bioequivalence Data Still Missing For Bupropion XL (Pink Sheet)
  • Merck to study industry use of cattle drug Zilmax (Reuters) (Reuters)
  • FDA OK's Silvergate's Epaned; new ped hypertension option (SCRIP)
  • FDA REMS Public Meeting Highlights from the Bench (FDA Lawyers Blog) (Part 2)
  • To Judge Sleep Aids, U.S. Looks at Drowsy Driving in the Morning (NYTimes)
  • FDA Grants Tentative Approval to Ranbaxy's Generic Vimovo (Naproxen/Esomeprazole Magnesium) (FDA)
  • FDA Grants Tentative Approval to Mylan for Generic Lescol (Fluvastatin) (FDA)
  • Alnylam Receives Orphan Drug Designation from U.S. Food & Drug Administration for ALN-AT3, an RNAi Therapeutic for the Treatment of Hemophilia (Alnylam)
  • Merrimack Pharmaceutical's MM-111 Granted Orphan Drug Status by FDA For Treatment of Advanced Gastric and Esophageal Cancers (PharmPro)
  • MannKind Report Positive PhIII Data From Afrezza Studies on Diabetic Patients (MK) (MK) (Reuters)
  • BMS drops antidepressant in phase IIb (PMLive)
  • Analyst: Celldex aiming at accelerated approval with brain cancer drug (BioFlash)
  • Hospira Recalls Certain Blood Bag Sets Due to Puncture Risk (FDA)
Pharmaceuticals: General
  • Lawmakers demand Purdue Pharma's list of suspect OxyContin prescribers (Fierce)
Medical Devices
  • Cutting the Wires: FDA Provides Industry Guidance (FDA) (FDA)
  • Can a plaintiff thread the preemption needle by alleging off-label promotion? (MedCity News)
  • FDA cites LumiQuick Diagnostics for marketing Dx tools without approval (Fierce)
  • Transcript: Dental Products Devices Panel Meeting from 18 July 2013 (FDA)
  • Scientific Information Request on Imaging Techniques for the Surveillance, Diagnosis, and Staging of Hepatocellular Carcinoma (AHRQ)
Assorted And Government
  • Gray Zone Between FDA And FTC Nutraceutical Regulation (Law 360)
  • Ex-Herbalife employee subpoenaed over 2011 safety concern: NYT (Reuters) (NYTimes)
  • FDA Plan Falls Short In Tailoring Information To Patient Subgroups, Advocate Says (IHP)
  • New Batch of FDA Warning Letters Posted (FDA)
  • Avoiding FDA 483s Strategy #1: Document, Document, Document (FDAzilla)
  • Does Regulation Work? (RegBlog)
  • Food Marketing Institute: FDA Should Clarify Importer Definition (IHP)
  • Conflicts of interest common among panel members of guidelines that expand disease definitions (EurekAlert)
  • 7 Ohio Cancer Docs Face Charges Over Drug Imports (Law 360)
  • SUBPOENAED: SEC further probes SciClone's foreign practices (SCRIP)
  • Meeting of the Presidential Advisory Council on HIV/AIDS (PACHA)
Upcoming Meetings And Events
  • 15 August 2013: Alliance for a Stronger FDA/FDA International Programs Meeting (Strengthen FDA)
  • 16 August 2013: Risk Communication Advisory Committee (FDA)
  • 19 August 2013: FDA Basics Webinar: Biological Products, Part 2: Biosimilar Biological Products (FDA)
  • 26 August 2013: WMA Declaration of Helsinki Meeting (WMA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • U.K. to launch center for personalized medicine diagnostics (BioCentury)
  • MHRA register of in-house tests needed, says UK diagnostics industry (Clinica)
  • Novartis tops list of EU products under "additional monitoring" (SCRIP)
  • Swiss OK for Takeda's schizophrenia drug lurasidone (Pharma Times)
  • Discounts prompt Scots yes to fund Intermune's Esbriet and Gilead's Stribild (SCRIP)

Asia

  • China FDA Highlights Product Recalls, Manufacturers Urged To Make Rapid Responses (PharmAsia)
  • China to launch fresh pharmaceutical bribery probe: Xinhua (Reuters)
  • Indian Health Ministry plans amend Rules to allow drug inspectors to draw samples from retail shops (PharmaBiz)
  • Indian Health ministry not to lift ban on pain-killer drug analgin (PharmaBiz)
  • Cardica shoots for Japanese approval (Mass Device)

Other International

  • South Africa seeking mutual recognition with FDA and EMA (Drug Wonks)
  • WHO getting ready to unveil norms on prequalification of finished pharmaceuticals (PharmaBiz)
  • Health Canada Approves GSK's Breo Ellipta (HC)
  • Avioq Announces Health Canada Approval and Canadian Launch of HTLV-I/II Test (Avioq)

General Regulatory And Interesting Articles

  • MedPharm's 'Patch-in-a-Can' Drug Delivery Tech Granted New Patents (In-Pharma)

Regulatory Reconnaissance #131  - 14 August 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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