Regulatory Focus™ > News Articles > Regulatory Recon: FDA's Woodcock Explains Agency's Stance on Abuse-Resistant Opioids (10 November 20

Regulatory Recon: FDA's Woodcock Explains Agency's Stance on Abuse-Resistant Opioids (10 November 2014)

Posted 10 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA's Woodcock Explains Agency's Stance on Abuse-Resistant Opioids (10 November 2014)

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

In Focus: US

  • FDA's Janet Woodcock Explains Agency's Stance on Abuse-Resistant Opioids (BioCenturyTV)
  • Skipping Past Congress: Limited Use For AZ/Actavis Antibiotic Gets FDA Review (Pink Sheet-$)
  • First data flows from national registry tracking joint replacements (Modern Healthcare)
  • Legislation on medical innovation may keep IT loosely regulated (Modern Healthcare)
  • Suit Against FDA Challenged Legality of FDA’s Detention Without Physical Examination Process for Imports of Medical Devices and Reminds us that Sometimes Litigation is the Answer (FDA Law Blog)
  • FDA spending could be tightened under Republicans (SCRIP-$)
  • Whatever Happened to Pharmaceutical Swag? (The Atlantic)

In Focus: International

  • Patient Reported Outcomes in Orphan Drug Submissions: Do They Make a Difference? (Context Matters)
  • What's in store at MHRA under NICE man Rawlins? (SCRIP-$)
  • Apex Committee turns down DCGI's proposal on trial approval for FDCs, subsequent new drugs, vaccines (PharmaBiz)
  • Pork Belies: Will traceability regs see China lose dominance of global heparin market? (In-Pharma)
  • China sets new requirements for hospitals running clinical trials (In-Pharma)

US: Pharmaceuticals and Biotechnology

  • Skipping Past Congress: Limited Use For AZ/Actavis Antibiotic Gets FDA Review (Pink Sheet-$)
  • FDA's Janet Woodcock Explains Agency's Stance on Abuse-Resistant Opioids (BioCenturyTV)
  • Safety Concerns Slow Sales of Testosterone Therapy (Bloomberg)
  • Health Affairs Policy Brief on Biosimilars (Health Affairs)
  • FDA Streamlines Critical Path Innovation Meetings Process (FDA News-$)
  • FDA Sends RPG Lifesciences A Warning Letter Last Year. (Link) Now Indian Authorities Say its Generic Lipitor Isn't Meeting Quality Standards (PharmaBiz)
  • Edoxaban Review ‘Not About Comparative Efficacy,’ FDA Says (Pink Sheet-$)
  • Global Traceability Data Exchange: Troubled Waters Ahead (RxTrace)
  • Internet Changes Medication Sales Regulations (NJ Law Journal-$)
  • C-Path, IMI to benchmark PPP performance (BioCentury)
  • District Court sets accelerated date to resolve Takeda suit against FDA over Colcrys (PharmaLetter-$)

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

  • FDA Accepts Amgen's Biologics License Application For LDL Cholesterol-Lowering Medication Evolocumab (Press)
  • BMS claims advance with hepatitis C regimen (Pharmafile) (Press) (SCRIP-$)
  • Merck's Shortened Hep C Regimens Fall Short of Cure-Rate Goal (The Street) (Press) (Reuters) (Fierce)
  • Teva reports positive Phase III trials behind Qnasl, a nasal allergy treatment (DSN)
  • Repros’ Androxal Primed For NDA Submission, But Outcomes Study Looms (Pink Sheet-$)
  • Severe Epileptic Patients in Coma Respond to Sage Therapeutics Experimental Drug (The Street) (Xconomy) (Fierce)
  • FLINTy reception for Intercept (BioCentury)
  • ALLY Trial Demonstrates High Cure Rates for Investigational Daclatasvir and Sofosbuvir Combination among Genotype 3 Hepatitis C Patients (Press)
  • Results of Civacir® (Hepatitis C Immune Globulin) US Phase III clinical trial (Press)

US: Pharmaceuticals and Biotechnology: General

  • Whatever Happened to Pharmaceutical Swag? (The Atlantic)
  • After hepatitis C cure, companies target next big liver disease market (Reuters)
  • Cigna Agrees to Reduce H.I.V. Drug Costs for Some Florida Patients (NYTimes)
  • Calculating cost to treat all hepatitis C patients in USA (PharmaTimes)
  • Despite campaign talk, contraception plan not on GOP agenda (Washington Times)
  • US Capitol Capsule: US seeks to get TPP, 'Asia pivot' back on track (SCRIP-$)

US: Medical Devices

  • First data flows from national registry tracking joint replacements (Modern Healthcare)
  • Legislation on medical innovation may keep IT loosely regulated (Modern Healthcare)
  • Suit Against FDA Challenged Legality of FDA’s Detention Without Physical Examination Process for Imports of Medical Devices and Reminds us that Sometimes Litigation is the Answer (FDA Law Blog)
  • Power morcellation ban unlikely, but other FDA restrictions coming soon (Fierce)
  • New LDT Guidance Documents Face Scrutiny (GEN)
  • ReShape Duo Delivers Weight Loss In Sham-Controlled Pivotal Trial (Gray Sheet-$)
  • Device Recalled Over Software Issue (FDA) (FDA)
  • Recall for Siemens Diagnostic Device Over False Positives (FDA) (FDA)
  • SQI Diagnostics gets FDA clearance to market Celiac Panel in the US (Press)
  • Zimmer Announces FDA Clearance of the Stand-alone Optio-C Anterior Cervical System for use with Structural Allograft/Autograft (Press)

US: Assorted And Government

  • FDA spending could be tightened under Republicans (SCRIP-$)
  • Upton Regulatory Reform Project May Be Bigger, Bolder In Next Congress (Pink Sheet-$)
  • Sens. Hatch, Alexander Expected To Helm Health Panels In Senate (Pink Sheet-$)

Upcoming Meetings

Ebola Outbreak

  • The Inaccurate And Unfair WHO Attack On Pharma Ebola Efforts (Forbes)
  • Scientists tell U.S. - find recipe for Ebola cure in survivors' blood (Reuters)
  • Industry and scientists developing new devices to treat Ebola (Fierce)

Europe

  • Patient Reported Outcomes in Orphan Drug Submissions: Do They Make a Difference? (Context Matters)
  • CVMP Outcomes From 4-6 November Meeting (EMA)
  • What's in store at MHRA under NICE man Rawlins? (SCRIP-$)
  • Searching the EU Regulatory Agencies (Regulatory-Intelligence)
  • Germany Post AMNOG: Insights for BioPharma (BioPharm International)
  • France's ANSM Says Contraceptive Warnings May Have Helped Hundreds (ANSM)
  • NICE rejects arguments against wider statin use (OnMedica)
  • Helping Patients in Patient-Centered Approaches to Health (Applied Clinical Trials)
  • Italy cracks whip on health claim abusers - fines could reach €5m (Nutra-Ingredients)

India

  • Apex Committee turns down DCGI's proposal on trial approval for FDCs, subsequent new drugs, vaccines (PharmaBiz)
  • Insight On India – Highlights From The Week Of Nov 2-8, 2014 (24 Insight)
  • Karnataka drug control officers raid 6 quack clinics stocking drugs, pick samples of NSQ drugs from pharmacy outlets (PharmaBiz)
  • NGOs, experts express concern over Indo-US ‘bilateralism’ on Intellectual Property (PharmaBiz)
  • Centre to roll out training plan for stakeholders soon for nationwide survey of spurious, NSQ drugs (PharmaBiz)
  • Kerala plan to have own clinical trial registry not taken off as DC Dept yet to commence work (PharmaBiz)

China

  • Pork Belies: Will traceability regs see China lose dominance of global heparin market? (In-Pharma)
  • China sets new requirements for hospitals running clinical trials (In-Pharma)

Other International

  • IVD Interoperability Standard Could Improve Laboratory Efficiency (MDDI)
  • Ghana: ‘Good governance of pharma sector critical to sustain health insurance scheme’ (PharmAfrica)

General Regulatory And Interesting Articles

  • Allergic to Penicillin? You're Probably Not (NBC)
  • Google Wants to Store Your Genome (MIT Tech Review)
  • Combining The DNA Of Three People Raises Ethical Questions (NPR)

Regulatory Reconnaissance #437 – 10 November 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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