Regulatory Focus™ > News Articles > Regulatory Recon: Senate Democrats Tell FDA to Finish Lifting Gay Blood Ban (15 July 2015)

Regulatory Recon: Senate Democrats Tell FDA to Finish Lifting Gay Blood Ban (15 July 2015)

Posted 15 July 2015 | By Michael Mezher 

Regulatory Recon: Senate Democrats Tell FDA to Finish Lifting Gay Blood Ban (15 July 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

  • Senate Dems to FDA: Finish Lifting Gay Blood Donor Ban (The Hill) (Letter)
  • Panel Finds Gilead Hepatitis C Drugs are Cost-Effective (Bloomberg)
  • Calls for More FDA Training in Lead Up to User-Fee Negotiations (Gray Sheet-$)
  • Early Push To Require The HPV Vaccine May Have Backfired (NPR)
  • Pediatric Priority Review Vouchers: A Subtle Upgrade to Renewal Plans (FDA Law Blog)
  • Online Registry Improves Clinical Research Study Participation (MNT)
  • Lawmakers Introduce National "Right to Try" Bill (MDDI) (Pharmalot)
  • ACA Contraceptive Coverage Isn’t Burden on Religion, Court Rules (NYTimes) (Harvard Bill of Health)
  • Making Device Data More Meaningful (mHealthNews)

In Focus: International

  • FDA, EC and EMA Boost Collaboration to Advance Medicine Development and Evaluation (EMA)
  • EMA Releases Four New Bioequivalence Guides (EMA, Asenapine, Prasugrel, Sitagliptin, Zonisamide)
  • Celltrion Gets Russian Approval for Remsima (BiosimilarNews)
  • Fewer Swiss Medtech Notified Bodies as EU-Aligned Rules Enacted (Clinica-$)
  • ENVI Report on Fighting Antimicrobial Resistance (ENVI)
  • NHS England Making NICE Look Much Nicer? (PharmaPhorum)

US: Pharmaceuticals and Biotechnology

  • Panel Finds Gilead Hepatitis C Drugs Are Cost-Effective (Bloomberg)
  • Mylan Issues Reminder on Calcium Chloride Intravenous Infusion Prefilled Syringes Recall (FDA) (Mylan)
  • Cancer discovery links experimental vaccine and biological treatment (Pharmaceutical Processing)
  • Online registry improves clinical research study participation (MNT)
  • Early Push To Require The HPV Vaccine May Have Backfired (NPR)

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

  • Amgen Awaiting FDA Decision on Expanded Indication for Kyprolis (BioPharmaDive)
  • Seven Approvals, Two Fast-Tracks and Two Partial Holds Lifted (SCRIP-$)
  • Takeda Submits NDA for Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma (Drug Discovery & Development)
  • Sabin PDP advances world's first human hookworm vaccine (MNT)
  • Viking Therapeutics Submits Investigational New Drug (IND) Application for VK5211 (Press)

US: Pharmaceuticals and Biotechnology: General

  • Calls For More FDA Training In Lead Up To User-Fee Negotiations (Gray Sheet-$)
  • Pediatric Priority Review Vouchers: A Subtle Upgrade to Renewal Plans (FDA Law Blog)
  • Getting science monkey off FDA's back (SCRIP-$)
  • Biosimilar Code Blending By CMS Could Cause Tracking, Payment Problems (Pink Sheet-$)
  • Providers, Patients Demand Transparency for Biosimilar Use (MedPageToday)
  • What’s Ahead for mHealth Enabled Clinical Trials? (Geeks Talk Clinical)
  • Engaging Participants and Assuring Equity in the Precision Medicine Initiative (FasterCures)
  • Waiver of Informed Consent - proposed changes in the 21st Century Cures Act (PlaceboControl)
  • On research review boards, conflict-of-interest reporting improves (Reuters) (Pharmalot)

US: Medical Devices

  • FDA Letter to Intraocular Lens Labelers (FDA)
  • Ultrasound Accelerates Skin Healing, Especially for Diabetics and the Elderly (BioSpace)
  • Running A Few Tests on Theranos: Can Elizabeth Holmes Revolutionize Diagnostics? (Forbes)
  • Making Device Data More Meaningful (mHealthNews)
  • Could Dissolvable Microneedles Replace Injected Vaccines? New Vaccine Patch Protects Against Flu in Humans (MNT)
  • Luminex Submits Aries System, Herpes Assay for FDA Clearance (GenomeWeb)

US: Assorted and Government

  • Senate Dems to FDA: Finish lifting gay blood donor ban (The Hill)
  • Lawmakers Introduce National "Right to Try" Bill (MDDI) (Pharmalot)
  • Health Law’s Contraceptive Coverage Isn’t Burden on Religion, Court Rules (NYTimes) (Harvard Bill of Health)
  • The ACA birth-control controversy, made simple (SCOTUSblog)
  • McKesson Can Appeal Darvocet Remand Decision: Judge (Law360-$)
  • Only three U.S. states mandate recommended HPV vaccine (Reuters)

Upcoming Meetings and Events

Europe

  • Fewer Swiss Medtech Notified Bodies as EU-Aligned Rules Enacted (Clinica-$)
  • ENVI Report on Fighting Antimicrobial Resistance (ENVI)
  • EMA: Workshop on Extrapolation Across Age Groups (EMA)
  • EMA Releases Four New Bioequivalence Guides (EMA, Asenapine, Prasugrel, Sitagliptin, Zonisamide)
  • UK Pharma Group Touts Commitment to Reducing Animal Testing by Boosting In Vitro Testing (ABPI)
  • EU Funds Swedish Company's HIV Diagnostic Device in First Loan Under New InitiativeFierceMedicalDevices)
  • GlaxoSmithKline Joins the U.K.'s New Crick Institute for Open R&D (FierceBiotech)
  • Cystitis Treatment Should not Require a Prescription, GP Says (OnMedica)
  • Gorsky Stands by Remicade Longevity as Biosimilar Impact Hits Europe (SCRIP-$)
  • Biosimilar Infliximab Could Offset Access Inequities in East European Crohn's Patients (SCRIP-$)
  • NHS England Making NICE Look Much Nicer? (PharmaPhorum)
  • Innovation Review Seeks Patients’ Views on Access to New Medicines (Pharmaceutical Journal) (PharmaPhorum)

India

  • Regulators Survey of NSQ Drugs to Test 43000 Collected Samples (PharmaBiz)
  • ‘Ineffective’ Indian Price Controls Need Rethink: Study (PharmAsiaNews-$)

Canada

Australia

  • Presentation on the Transition to New Regulatory Framework for In Vitro Diagnostics (TGA)
  • Novogen Develops Drug to Enhance Chemotherapy Effect (BioSpectrum)

Ebola Outbreak                                            

Other International

  • Celltrion Gets Russian Approval for Remsima (BiosimilarNews)
  • Understanding the Extent of the Counterfeit and Substandard Drug Problem (PharmTech)

General Regulatory and Interesting Articles

  • FDA: Preparation for International Cooperation on Cosmetics Regulation (Federal Register)
  • New CDC Study Highlights Burden of Pneumonia Hospitalizations Among US Adults (CDC)
  • Taking Antidepressants With Painkillers Could Increase Risk of Hemorrhage (OnMedica)
  • Manipulating Microbes: New Toolbox for Better Health? (NIH)
  • Immunization: It’s a Population Health Issue (MedCityNews)
  • When Weed is the Cure: A Doctor's Case for Medical Marijuana (NPR)
  • Fitbit CEO Talks Software Focus, Future Acquisitions, and Blurring Fitness-Health (MobiHealthNews)

Regulatory Reconnaissance #596 – 15 July 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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