Regulatory Focus™ > News Articles > Regulatory Recon: What Ever Happened to that Vial of Smallpox FDA Found? (29 October 2014)

Regulatory Recon: What Ever Happened to that Vial of Smallpox FDA Found? (29 October 2014)

Posted 29 October 2014 | By Alexander Gaffney, RAC

Regulatory Recon: What Ever Happened to that Vial of Smallpox FDA Found? (29 October 2014)

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

In Focus: US

  • ‘Forgotten’ FDA smallpox virus languishes on death row (Nature)
  • Daiichi Sankyo gains little FDA support for a-fib drug edoxaban (BioCentury) (Fierce) (Tarius) (Reuters) (Pink Sheet-$) (SCRIP-$)
  • FDA Launches Webpage for its Drug Quality Samplling and Testing Programs (FDA)
  • FDA: Generic Bioequivalency Problems With Welbutrin XL a "Rare" Exception to the Norm (FDA)
  • FDA's Throckmorton Says Agency Moving Forward on Non-Clinical Cardiovascular Safety Testing (FDA)
  • FDA Is Making Progress Addressing ANDA Backlog, Officials Say (FDA News-$)
  • FDA warns Cook Medical on 'nonconformance' issues (Mass Device)
  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices (MedDeviceOnline)
  • Despite Emergency Authorization for Ebola Test, NY Officials Don't Allow its Use (ABC7)

In Focus: International

  • EMA update in sight on PIP class waiver revocations (SCRIP-$)
  • Guidelines and Concept Papers Adopted During the Most Recent CHMP Meeting (EMA)
  • Swissmedic OKs trial of GSK's adenovirus-based Ebola vaccine (BioPharma-Reporter) (Press) (WHO) (Bloomberg)
  • Regulatory compliance key for growing Middle East and North Africa Medtech market (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • Daiichi Sankyo gains little FDA support for a-fib drug edoxaban (BioCentury) (Fierce) (Tarius) (Reuters) (Pink Sheet-$) (SCRIP-$)
  • FDA Launches Webpage for its Drug Quality Samplling and Testing Programs (FDA)
  • FDA: Generic Bioequivalency Problems With Welbutrin XL a "Rare" Exception to the Norm (FDA)
  • FDA's Throckmorton Says Agency Moving Forward on Non-Clinical Cardiovascular Safety Testing (FDA)
  • FDA Is Making Progress Addressing ANDA Backlog, Officials Say (FDA News-$)
  • Indian drugmaker Ranbaxy still has exclusive rights for Nexium generic: CEO (Reuters) (MM&M)
  • FDA Could Find Room For Innovative Switches Under Existing Regs (Tan Sheet-$)
  • Small GDUFA Oversights Put Many Generics Firms in Arrears (FDA News-$)
  • Hamburg: FDA focuses on progress for breast cancer patients (HuffPo)

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

  • DARA BioSciences Petitions FDA to Amend Label for Tamoxifen Citrate and Soltamox to Extend Duration of Adjuvant Therapy to 10 Years (Press)
  • Akebia dives following safety concerns for lead drug in Phase IIb (SCRIP-$)
  • Sarcoidosis-Associated Small Fiber Neuropathy Therapy Fast Tracked by FDA (MPR)
  • Belviq & Phentermine: A Diet Drug Cocktail In The Making? (RTT) (Press)
  • Cara's pain drug clears an abuse hurdle as it trots toward Phase III (Fierce)
  • FDA Grants Kamada Orphan Drug Designation for the Treatment of Graft versus Host Disease (Press)

US: Pharmaceuticals and Biotechnology: General

  • Sanofi Chief Viehbacher Ousted After Board Tensions (Bloomberg)
  • Price Drop for $57,000 Snakebite Drug May Arrive in 2018 (Bloomberg)
  • Study: Rx Painkillers Place 'Substantial' Burden on Hospitals (CA Healthline)

US: Medical Devices

  • FDA warns Cook Medical on 'nonconformance' issues (Mass Device)
  • Bridging The FDA-CMS Divide: An Optimized Route To Market For Medical Devices (MedDeviceOnline)
  • Software Problems Lead to Recall for Ventilator (FDA)
  • Successful De Novo Petitions Double With Advent Of Direct Route (Gray Sheet-$)
  • Nephros Receives 510(k) Clearance for DSU-H and SSU-H Ultrafilters (Press)
  • Medtronic launches surgical aortic valve trial (Mass Device)

US: Assorted And Government

  • ‘Forgotten’ FDA smallpox virus languishes on death row (Nature)
  • The regulation election (The Hill)
  • Indiana Brothers Convicted In Texas Drug Case (CBS DFW)

Upcoming Meetings

Ebola Outbreak

  • Despite Emergency Authorization for Ebola Test, NY Officials Don't Allow its Use (ABC7)
  • In Ebola Crisis, New Vaccine Candidates Show Uncertain Promise (Forbes)
  • Swissmedic OKs trial of GSK's adenovirus-based Ebola vaccine (BioPharma-Reporter) (Press) (WHO) (Bloomberg)
  • Chimerix hammers out an emergency PhII Ebola study for antiviral (Fierce)
  • Cornyn asks Obama administration about status of Ebola vaccine research (The Hill)
  • US military seeks to accelerate Ebola drugs, vaccines (SCRIP-$)

Europe

  • EMA update in sight on PIP class waiver revocations (SCRIP-$)
  • Guidelines and concept papers Adopted during the CHMP meeting 20-23 October 2014 (EMA)
  • RoHS Is a RoHS Is a RoHS (EMDT)
  • EDQM sets new policy for testing of bacterial endotoxins (In-Pharma)
  • Medicines regulator reviews chloramphenicol packaging after picking errors (PharmJournal)

India

  • India relies on China for 90 per cent of drug raw materials (India Times)

Other International

  • Regulatory compliance key for growing Middle East and North Africa Medtech market (SCRIP-$)
  • Neuro experts call for drug name shake-up; manufacturers more cautious (In-Pharma)
  • DCVMN International to quicken access to affordable vaccines (India Times)

Clinical Trials

  • NIH Proceeds with Caution on Sex Balance in Biomedical Studies (SciAm)
  • Jonas Salk's Polio Vaccine Trials Would Be Hard To Repeat Today (NPR)
  • A retrospective analysis: the development of patient reported outcome measures for the assessment of Crohn's disease activity (PubMed)
  • FDA's Throckmorton Says Agency Moving Forward on Non-Clinical Cardiovascular Safety Testing (FDA)

General Regulatory And Interesting Articles

  • Jonas Salk didn’t patent his vaccine, but that doesn’t mean others shouldn’t (Slate) (DrugWonks) (LATimes)
  • Design Rationale and Medical Devices: Why Is it Designed and Manufactured the Way it Is? (EMDT)
  • Google's latest "moon shot": A pill to detect cancer (CBS)
  • Advanced ovarian cancer may someday be detected with tampons (Reuters)

Regulatory Reconnaissance #429 – 29 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 news@raps.org.

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


Categories: Recon, Regulatory News

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