Regulatory Recon: Hamburg Defends US Device Approval System (8 October 2014)

Posted 08 October 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Hamburg Defends US Device Approval System (8 October 2014)

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

In Focus: US

In Focus: International

  • Ebola Vaccine Trials May Give Placebo to Those at Risk (Bloomberg)
  • IMDRF Opens Consultation on National Competent Authority Report (NCAR) Exchange Criteria and Report Form (IMDRF)
  • UK cost agency rejects British company GW's cannabis drug (Reuters)
  • Scotland doubles funding for access to new medicines (PharmaTimes) (PharmJournal) (SCRIP-$) (BioCentury)
  • Current and mostly future UDI developments in the EU (MDL)

US: Pharmaceuticals and Biotechnology

  • Safety, sanitary problems prompt scores of drug recalls (USA Today)
  • Biosimilar workflow growing at CDER (BioCentury)
  • Alexion’s Soliris REMS Gets FDA Panel Review In Wider Evaluation Effort (Pink Sheet-$) (FDA) (Tarius) (BioCentury)
  • Bristol-Myers Withdraws New Drug Application For Asunaprevir (RTT) (Pink Sheet-$) (Pharmafile) (BioCentury) (PharmaTimes) (Reuters) (SCRIP-$)
  • FDA Science Board to review the existing nonclinical and clinical data related to the use and potential toxicity of anesthetics and sedation drugs in the pediatric population (FDA) (Tarius)
  • FDA Approves UCERIS (Budesonide) 2mg Rectal Foam for the Induction of Remission of Mild-to-Moderate Distal Ulcerative Colitis (Press)
  • USP chief underscores value of harmonization (SCRIP-$)
  • Existing FDA pathways have potential to ensure early access to, and appropriate use of, specialty drugs (PubMed)
  • FDA Clears Path for Generic Endometriosis Drug, Lupon Depot (FDA)
  • Controlling for Particulate Matter in Injectable Drug Products (USP)
  • FDA warns some over-the-counter meds may impair driving (CBS)
  • "Right to Try" Initiative on Ballot in Arizona (AZCentral)

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

  • Teva Initiates NDA For CEP -33237, Records Positive Results For Abuse Liability (RTT)
  • Chimerix scores promising antiviral data from a controversy-fueled PhIII pilot (Fierce) (Press) (SCRIP-$) (Reuters)
  • Positive PhIII PONV study brings little Acacia to a crossroads (Fierce) (BioCentury)
  • DNAtrix's Oncolytic Adenovirus Designated Orphan Drug for Malignant Glioma (MPR)
  • Nabriva Therapeutics Announces Qualified Infectious Disease Product and Fast Track Status Granted by the US FDA for Lefamulin (Press)

US: Pharmaceuticals and Biotechnology: General

  • ​Officials Question the Rising Costs of Generic Drugs (NYTimes) (SCRIP-$)
  • 'Decision fatigue' may lead docs to prescribe unnecessary antibiotics (Reuters)

US: Medical Devices

  • FDA aiming to speed OK of medical devices (Boston Globe)
  • FDA Commissioner tackles medical device outsourcing to Europe – and gets a pointed rebuttal (MedCityNews) (MDDI)
  • 510(k) Means Substantial Equivalence...Unless Your Device Has Software (FDA Law Blog)
  • Citizen Device Hackers Meeting With FDA Oct. 8 (Gray Sheet-$)
  • Novel Boston Scientific Device Headed For Another Rough FDA Panel (Forbes)
  • uChek-maker Biosense to launch pilot with Merck for Mothers (MobiHealthNews)
  • Kubtec Announces FDA Approval of World’s First Breast Specimen Tomosynthesis System During Breast Cancer Awareness Month (Press)
  • Hudson RCI Pediatric Anesthesia Breathing Circuits by Teleflex Medical: Class I Recall - Circuit Ends May Crack or Break (FDA) (FDA)
  • SAM Medical Products Implements Voluntary Recall of its Accessory (Axilla) Strap for the SAM Junctional Tourniquet (FDA)

US: Dietary Supplements

  • Scientists warn about new stimulant in workout supplements (Daily World) (Wiley) (LiveScience)
  • Manzo Pharmaceuticals' Probiotic Will Not Need FDA Approval (DD&D) (Press)
  • Top 10 Things to Know Before Exporting Supplements to the United States (NPI)

US: Assorted And Government

  • FDA Science Board to Examine Commission's Fellowship Program (Tarius)

Upcoming Meetings

Ebola Outbreak

  • Ebola Vaccine Trials May Give Placebo to Those at Risk (Bloomberg)
  • Fast-tracking an Ebola vaccine may prove too slow (CNBC)
  • Ebola Vaccine — An Urgent International Priority (NEJM)
  • Can chocolate bars with silver nanoparticles cure Ebola? FDA Commissioner riffs on fraud (MedCityNews)
  • Dietary Supplement Industry Warns Consumers Regarding Ebola Claims (NPI)
  • Tekmira Working Hand In Hand With WHO On Ebola Drug, Says CEO (BioSpace) (Xconomy)



  • Lucentis (ranibizumab) approved by Health Canada to treat vision loss resulting from choroidal neovascularization in pathologic myopia (mCNV)(1) (Press)

Other International

  • IMDRF Opens Consultation on National Competent Authority Report (NCAR) Exchange Criteria and Report Form (IMDRF)
  • GSK Investigating Corruption Allegations In UAE (Law 360-$)
  • Uptake of biosimilars across Latin America surges as regulations vary (Biopharma Reporter)

Clinical Trials

  • Researcher Financial Conflicts Influence Flu Drug Studies (Bloomberg) (Pharmalot)
  • U.S Troops and Patients Were Used as Malaria Guinea Pigs: Book (NBC)
  • The Great Bluff That Led To A 'Magical' Pill And A Sexual Revolution (NPR)

General Regulatory And Interesting Articles

  • Share API audits or see quality slump, says Hovione (Outsourcing Pharma)
  • What 20 Years Of Research Has Taught Us About The Chronic Effects Of Marijuana (Forbes)
  • Stop watching this video and go get a flu shot (Vox)

Regulatory Reconnaissance #416 – 8 October 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

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

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