Regulatory Focus™ > News Articles > Regulatory Recon: FDA Responds to Congress on Opioid Black Boxes (27 August 2015)

Regulatory Recon: FDA Responds to Congress on Opioid Black Boxes (27 August 2015)

Posted 27 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Responds to Congress on Opioid Black Boxes (27 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products (FDA)
  • 1 in 4 Hepatitis C Patients Denied Initial Approval for Drug Treatment (ICT)
  • Monoclonal Antibodies in Multiple Myeloma Come of Age (NEJM)
  • Antiprotozoal Activity Profiling of Approved Drugs: A Starting Point toward Drug Repositioning (PLOS)
  • Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile (FDA)
  • FDA Clashes with Congress Regarding Untitled Letters (FDA Law Blog) (FDA)
  • FDA Responds to Concerns from Lawmakers on Opioid Black Boxes (FDANews-$) (FDA)

In Focus: International

  • Internal validity of non-randomised studies (NRS) on interventions (EUnetHTA)
  • Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness (EUnetHTA)
  • NICE recommends tighter glucose control in updated diabetes guidelines (Pharmaceutical Journal-$)
  • UK's NICE recommends Takeda's Entyvio for Crohn's disease (PharmaLetter-$)
  • UK's NHS commissions new TB drugs for first time in 50 years (BioPharmaDive)
  • Japanese Agency Looks to Remap Country's Research Funding Landscape (GenomeWeb)
  • MHLW urges Japan's generics sector to consolidate (In-Pharma Technologist)
  • The Ebola virus vaccine is effective. But the fight goes on. (WHO)
  • Korean, Foreign Pharms Call For ‘Reasonable’ Drug Price System (PharmAsiaNews)

US: Pharmaceuticals and Biotechnology

  • Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products (FDA)
  • 1 in 4 Hepatitis C Patients Denied Initial Approval for Drug Treatment (ICT)
  • Monoclonal Antibodies in Multiple Myeloma Come of Age (NEJM)
  • Antiprotozoal Activity Profiling of Approved Drugs: A Starting Point toward Drug Repositioning (PLOS)
  • Pharmaceutical Brand Marketing: Begin Brand Assessment as Soon as Pre-Clinical Development (Cutting Edge Info)

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

  • Novel Drug Granted Orphan Designation for Rare Musculoskeletal Disorder (MPR)
  • Amgen Submits NDA for Novel Hyperparathyroidism Drug (FDANews)
  • Pfizer starts Ibrance trials in early breast cancer (PMLive)
  • Novo to begin Phase III trial of oral diabetes treatment (Reuters)
  • Results From the AMBITION Study of First-Line Treatment With Letairis and Tadalafil in Pulmonary Arterial Hypertension (Press)

US: Pharmaceuticals and Biotechnology: General

  • Kim Kardashian is not a role model for medical advice. She’s just using you. (MedCityNews)
  • Will FDA Finally Give Up On Trampling Free Speech? (BioSpace)
  • Three Things I’ve Learned about Quality Professionals (Master Control)

US: Medical Devices

  • Class II Special Controls Guideline Document: Toxin Gene Amplification Assays for the Detection of Clostridium difficile (FDA)
  • Texting Helps Diabetes Patients Fine-Tune Insulin Dosing (NPR)
  • Firms Bristle At Labeling Requirements For Patient-Preference Data (Gray Sheet-$)
  • Team identifies the off switch for biofilm formation (PhysOrg) (GEN)
  • BioControl Medical Completes Enrollment in the INOVATE-HF Study of the CardioFit® System to Treat Heart Failure (Press)
  • AirXpanders' tissue expander for breast reconstruction meets primary endpoint (FierceMedicalDevices)
  • New e-pill Auto Dispensing System to Improve Med Adherence (MPR)
  • FDA issues another Class 1 recall for Teleflex (MassDevice)
  • Post-approval interim data on ALS neurostim device confirms survival benefit (FierceMedicalDevices)

US: Assorted and Government

  • FDA Clashes with Congress Regarding Untitled Letters (FDA Law Blog) (FDA)
  • FTC Urges FDA to Reevaluate Current Approach To Regulating Homeopathic Drugs (Policy and Medicine) (Focus)
  • Experts Agree: 21st Century Cures is Good for Patients, Researchers, and the Economy (USHR)
  • 21st Century Cures: A Life-Saving Investment (USHR)
  • FDA Responds to Concerns from Lawmakers on Opioid Black Boxes (FDANews-$) (FDA)
  • FDA Seizures Don't Negate Layoff Notice Rule: 6th Circ. (Law360-$)
  • Social Media/Mobile Health Data: What's It Good For? (SCRIP-$)
  • US patent office puts new Copaxone's IP shield under the lens (FiercePharma)
  • FDA wants food companies to hand over their pathogens (Reuters)
  • Misrepresentation Claim Still Alive In Bayer IUD Liability Suit (Law360-$)
  • Seattle Children's Hospital says surgical equipment may have been unsterile (CBS News)
  • Janssen, Celltrion Brawl Over Fed. Circ. Biosimilar Ruling (Law360-$)
  • Bristol-Myers, Sanofi prevail in Plavix false claims case (BioPharmaDive)

Upcoming Meetings and Events              

Europe

  • Internal validity of non-randomised studies (NRS) on interventions (EUnetHTA)
  • Process of information retrieval for systematic reviews and health technology assessments on clinical effectiveness (EUnetHTA)
  • NICE recommends tighter glucose control in updated diabetes guidelines (Pharmaceutical Journal-$)
  • Renishaw Dx Lands CE Mark for MDx System, Fungal Assay (GenomeWeb)
  • UK's NICE recommends Takeda's Entyvio for Crohn's disease (PharmaLetter-$)
  • UK's NHS commissions new TB drugs for first time in 50 years (BioPharmaDive)
  • St. Jude Medical Receives CE Mark For Industry's Only MR-Conditional Rechargeable Spinal Cord Stimulator Approved To Offer Burst Stimulation (MedDeviceOnline)

Canada

Australia

  • TGA approves Hospira's biosimilar Inflectra (BioSpectrum)

India

  • India Tweaks Audio-Visual Norms For Trials (SCRIP-$)
  • CDSCO sets up panel for regulating online pharmacy, first meeting in a couple of weeks (PharmaBiz)
  • Lupin gets USFDA nod for generic ulcer drug (Economic Times)
  • Aurobindo Pharma gets USFDA nod for hepatitis B drug Entecavir (Economic Times)
  • Government caps price of 18 formulation packs (Economic Times)

Japan

Ebola Outbreak

  • The Ebola virus vaccine is effective. But the fight goes on. (WHO)
  • Fujifilm/MediVector Antiviral Favipiravir May Protect Against Ebola (SCRIP-$)

Other International

  • Korean, Foreign Pharms Call For ‘Reasonable’ Drug Price System (PharmAsiaNews)

General Health and Other Interesting Articles

  • Life 2.0? Synthetic DNA Added to Genetic Code (Discovery News)
  • Global life expectancy rises, but people live sicker for longer (Reuters)
  • For marijuana and the brain, questions remain (Reuters)
  • How The Prescription Painkiller Fentanyl Became A Street Drug (NPR)

Regulatory Reconnaissance #627 – 27 August 2015

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 @Michael_Mezher 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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