Regulatory Focus™ > News Articles > Regulatory Recon: FDA Spying Lawsuit Dismissed (25 September 2014)

Regulatory Recon: FDA Spying Lawsuit Dismissed (25 September 2014)

Posted 25 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Spying Lawsuit Dismissed (25 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register here, or check out some of the mostnews-worthy sessions here.

In Focus: US

  • Judge Dismisses Lawsuit Filed by FDA Whistleblowers (FDL) (Law 360-$) (WaPo)
  • FDA reorg splits CIO, informatics roles in preparation for network innovations (Federal News Radio)
  • FDA's Mini-Sentinel to Exit Pilot Stage on 1 October 2014 (Nature) (SciAm)
  • Shire to pay $56.5 million to settle allegations it inappropriately promoted ADHD drugs (Inquirer) (Pharma Times) (Market Watch) (Reuters)
  • FDA Says it Plans to Release Final Veterinary Feed Directive in 2015 (FDA)
  • New FDA Label Bolsters Safety Case for Chantix (AP) (Pharmalot)
  • What Legal Authority Does FDA Have to Regulate Medical Device Promotion on Internet Social Media Platforms? (FDA Law Blog)

In Focus: International

  • Medical Device Legislation to be Top Issue With New EU Presidency (EU Parliament)
  • EMA Releases New Guideline on Irritable Bowel Syndrome (EMA)
  • Indian CRO hit with warning letter from French regulator (Outsourcing Pharma)
  • NPPA powers not withdrawn, says Government (India Times)
  • Apotex Agrees to Canadian Demand to Quarantine Products (Press)

US: Pharmaceuticals and Biotechnology

  • FDA's Mini-Sentinel to Exit Pilot Stage on 1 October 2014 (Nature) (SciAm)
  • Shire to pay $56.5 million to settle allegations it inappropriately promoted ADHD drugs (Inquirer) (Pharma Times) (Market Watch) (Reuters)
  • Questions Raised Over Differences Between Brand Name Rx Drugs vs. Generics (ABC)
  • FDA Says it Plans to Release Final Veterinary Feed Directive in 2015 (FDA)
  • New FDA Label Bolsters Safety Case for Chantix (AP) (Pharmalot)
  • How Many Drugs Have Ever Been Approved by FDA? Not as Many as You Might Think (Medical Xpress)
  • Impax settles securities suit tied to its manufacturing issues (Fierce)
  • The FDA Drug Shortage Assistance Award… Recognizing manufacturers who help prevent or alleviate drug shortages (FDA)
  • Boehringer Ingelheim Announces FDA Approval of Spiriva Respimat (tiotropium bromide) Inhalation Spray for the Maintenance Treatment of COPD (Press)
  • AbbVie's HUMIRA (adalimumab) Receives U.S. FDA Approval for the Treatment of Pediatric Patients with Moderately to Severely Active Crohn's Disease (Press)
  • FDA Celebrates Hatch-Waxman's 30th Anniversary (FDA)
  • Shoot First … Michigan Imposes New Requirements on the Pharmaceutical Supply Chain (Porzio)
  • Noven Receives FDA Approval of a New Indication with a New Dose for Minivelle (Estradiol Transdermal System) (Press)
  • Actavis to keep selling Alzheimer's drug in U.S. for 60 days (Reuters)

US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations

  • FDA accepts NDA for Otsuka's brexpiprazole (BioCentury)
  • Roche says Avastin prolongs life in breast cancer study (Reuters)
  • Novartis reports positive trials for arthritis drug (Reuters) (PharmaPhorum)
  • AZ's Byetta on par with Lilly's Humalog in sugar control (Pharma Times)
  • Lipocine's low-T drug hits the mark in Phase III. Now it has to sway the FDA (Fierce) (Reuters)
  • BioMarin Submits Paragraph IV Certification to FDA for Approval of Kuvan (Press)
  • Nicox gets boost from strong prospects for glaucoma drug (Reuters) (Press)
  • MabVax Therapeutics Receives Orphan Drug Designation for Therapeutic Vaccine to Treat Childhood Cancer Neuroblastoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • NIH launches study of 'exceptional responders' to cancer therapies (Fierce)
  • White House tells universities to police work on dangerous pathogens (Reuters) (SCRIP-$) (NYTimes)
  • Planned Parenthood pilots video visit app to prescribe birth control (MobiHealthNews)
  • NIH announces network to accelerate medicines for rheumatoid arthritis and lupus (NIH)

US: Medical Devices

  • Judge Dismisses Lawsuit Filed by FDA Whistleblowers (FDL) (Law 360-$) (WaPo)
  • FDA clears glucose monitoring system for use in hospital critical care units (FDA)
  • What Legal Authority Does FDA Have to Regulate Medical Device Promotion on Internet Social Media Platforms? (FDA Law Blog)
  • 23 notable FDA clearances for digital health apps, devices so far this year (MobiHealthNews)
  • FDA Releases "Policy Clarification" for Fluoroscopic Requipment in new Draft Guidance (FDA)
  • Medical Device Cyber Security: Act Now or Pay Later (MDDI)
  • Renal Denervation Researcher Argues Sham Control is Ethically Necessary (Gray Sheet-$)
  • First OTC Conception Assistance Device Cleared (EMPR)
  • Cynosure product wins expanded FDA approval (Lowell Sun)

US: Dietary Supplements

  • States Should Restrict Weight Loss, Bodybuilding Supplement Sales – Study (Tan Sheet-$)
  • History of Supplement Safety Regulations (NPI)

US: Assorted And Government

  • FDA reorg splits CIO, informatics roles in preparation for network innovations (Federal News Radio)

Upcoming Meetings

Ebola Outbreak

  • How the U.S. Screwed Up in the Fight Against Ebola (Bloomberg)
  • Can Ebola "Bombs" Be Made for Warfare? (SciAm)

Europe

  • Medical Device Legislation to be Top Issue With New EU Presidency (EU Parliament)
  • EMA Releases New Guideline on Irritable Bowel Syndrome (EMA)
  • Indian CRO hit with warning letter from French regulator (Outsourcing Pharma)
  • Risks of online pharmacies prompts review by UK regulator (PharmJournal)
  • More movement – new rapporteur for MDR, same for IVDR (Medical Devices Legal)
  • U.K. panel under pressure to extend use of Merck's Gardasil to boys (Fierce) (PharmJournal)

India

  • NPPA powers not withdrawn, says Government (India Times)
  • Is the Indian clinical trials segment pick up a mirage? (SCRIP-$)

Canada

  • Apotex Agrees to Canadian Demand to Quarantine Products (Press)
  • Canada finally gets new top doctor (Ottawa Citizen)

Australia

  • TGA reforms: A blueprint for TGA's future: Progress report as at 30 June 2014 (TGA)

Other International

  • Brazil releases 'good' mosquitoes to fight dengue fever (BBC)
  • Egypt Negotiates $300 Price For Gilead's Hep C Drug (PharmAsia-$)

Regulatory Reconnaissance #407 – 25 September 2014

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.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Categories: Recon, Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe