Regulatory Focus™ > News Articles > Regulatory Reconnaissance (10 October 2013)

Regulatory Reconnaissance (10 October 2013)

Posted 10 October 2013 | By Alexander Gaffney, RAC 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

In Focus: International

  • EMA to host workshop on prevention of product shortages due to manufacturing and quality problems (EMA)
  • IQWiG: Key data missing from public trial reports (Pharma Times) (PLoS) (MNT) (EurekAlert) (PMLive)
  • ABPI announces review of Code (PMLive)
  • India's clinical trials called into question again, industry watching (MedCity News)

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

US: Pharmaceuticals/Biotechnology

  • What Happens to FDA's CDER-and Industry-When Janet Woodcock Retires? (Reuters)
  • FDA Details Shutdown Finances, has Enough PDUFA Fees for Two Months of Operations (BioCentury)
  • As Maine's Drug Importation Law Goes Into Effect, State Seeks Dismissal of Lawsuit to Block Implementation (FDA Law Blog) (Drug Wonks)
  • FDA committee to discuss Chelsea's Northera (BioCentury) (Press)
  • Asthma Sprays Primatene Mist, Asthmanefrin Await FDA Decisions (Pink Sheet-$)
  • Gilead drug works against leukemia, trial stopped early (Reuters) (Pharma Letter-$) (SCRIP-$) (Fierce) (BioSpectrum)
  • Cirrus -Kemwell Receives FDA Grant to Evaluate Formulation Effects on MDI Performance (Press)
  • Actavis files ANDA for Reckitt generic with FDA  (BioSpectrum)
  • Pfizer drug shows mixed results in psoriasis trials (Reuters) (SCRIP-$)
  • Pfizer's Xeljanz In Psoriasis Does Best At Dose That Worried FDA (Pink Sheet-$)
  • Alkermes Receives Fast Track Designation for ALKS 5461 for Major Depressive Disorder (Press)
  • Novoteris, LLC. Receives Orphan Drug Designation for Nitric Oxide for the Treatment of Cystic Fibrosis (Press)
  • Lundbeck and Otsuka take Alzheimer's drug into phase III (PMLive)
  • Tamiflu Drug Shortage Ends (FDA)
  • FDA decision on BioDelivery's Bunavail expected June 2014 (SCRIP-$)
  • No serious adverse reactions to HPV vaccination (EurekAlert)
  • Pharma Co. Misled Investors About Hepatitis Drug, Suit Says (Law 360-$)
  • Could FDA Inspections be Less Thorough During the Shutdown? (FDAzilla)

US: Pharmaceuticals and Biotechnology: General

  • Biosimilar uptake will be quicker in USA: Fitch (Pharma Times)

US: Medical Devices

  • CardioMEMS Heart Failure Device Gets Mixed Reception (but Approval) From FDA Advisory Panel (Forbes) (Cardiovascular Business) (MedPage Today) (MedCity News) (Mass Device)
  • Developing a Mobile Medical App? Don't Forget Human Factors! (MDDI)
  • Brainlab Announces FDA Clearance for Airo Mobile Intraoperative CT (Press)
  • Advanced Catheter Therapies Receives FDA Approval for Occlusion Perfusion Catheter  (MedGadget)
  • MAQUET Medical Systems USA Receives 510(k) Clearance for VOLISTA Surgical Lighting System (Press)

US: Assorted And Government

  • NIH enrolls a dozen critically ill patients despite shutdown (NBC) (NYTimes) (BioCentury)
  • Animal Studies Being Put to the Test (WSJ)

Upcoming Meetings And Events

  • October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
  • 16 October 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • EMA to host workshop on prevention of product shortages due to manufacturing and quality problems (EMA)
  • IQWiG: Key data missing from public trial reports (Pharma Times) (PLoS) (MNT) (EurekAlert) (PMLive)
  • ABPI announces review of Code (PMLive)
  • Apricus ED drug gains national phase approval in Germany (Pharma Letter-$)
  • Scots HTA approves four products, but more disappointment for Roche's Perjeta (SCRIP-$)
  • France's ANSM Says Baxter's Numeta Runs Risk of Hypermagnesaemia (ANSM)

Asia

  • India is exporting tainted drugs, and getting away with it (Chicago Tribune)
  • India's clinical trials called into question again, industry watching (MedCity News)

General Regulatory And Interesting Articles

  • An Innovation For Pain Relief That's Worthy Of Some Buzz (NPR)
  • Why Scientists Held Back Details On A Unique Botulinum Toxin (NPR)
  • Faulty Assay Sets Stage for $500,000 Snafu (MedPage Today)

Regulatory Reconnaissance #175 - 10 October 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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