Regulatory Focus™ > News Articles > Regulatory Recon: Democrats Call on FDA to Change Blood Donor Rule; CFDA to Require Self Inspections

Regulatory Recon: Democrats Call on FDA to Change Blood Donor Rule CFDA to Require Self Inspections for Class II & III Device Distributors (15 June 2016)

Posted 15 June 2016 | By Michael Mezher 

Regulatory Recon: Democrats Call on FDA to Change Blood Donor Rule CFDA to Require Self Inspections for Class II & III Device Distributors (15 June 2016)

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

In Focus: US

  • I Am a Gay Man From Orlando. Why Can't I Donate Blood? (NYTimes)
  • House Democrats Continue Call for FDA Blood Donor Rule Changes (Morning Consult)
  • Biotech employee charged with insider trading based on study results (STAT) (Law360-$)
  • Should We Sequence the DNA of Every Cancer Patient? (MIT Technology Review)
  • How drug companies use gifts and internships to buddy up to their most valuable patients (Washington Post)
  • Woodcock: Antibiotics Pipeline is 'Fragile and Weak' (Focus) (BioWorld) (WSJ-$)
  • Can you teach old drugs new tricks? (Nature)
  • Marathon Pharma submits application for Duchenne muscular dystrophy drug to FDA (PharmaFile) (Pink Sheet-$)
  • Cholesterol Skeptics Launch Another Attack (CardioBrief)
  • Califf: New FDA guidance to ensure all drug info is available to patients (In-PharmaTechnologist)
  • FDA's Oncology Leader Sends The Wrong Message On Immuno-Oncology Drug Research (Forbes)
  • FDA Strengthens SGLT-2 Kidney Risk Warnings (Medpage) (FDA)

In Focus: International

  • Russia's Biocad to file lawsuit against Roche in US court (PharmaLetter-$)
  • UN Development Agency Issues Guidelines For Pharmaceutical Patent Examiners (IP Watch)
  • WHO guideline offers advice for when child-friendly medicines are unavailable (Pharmaceutical Journal)
  • Asia Regulatory Roundup: CFDA Outlines Five-Year Training Program Following Government Criticism (Focus)
  • German Supreme Court grants Lilly appeal to block Alimta generics (Pharmafile) (Press)
  • Novartis says to develop antimalarial treatment with Medicines for Malaria Venture (Pharmafile)
  • Chinese FDA Requiring Self Inspections for Class II and III Medical Device Distributors (Emergo)
  • Australian Govt Needs To Tackle Low Biosimilar Awareness, Switching Concerns (PharmAsiaNews-$)

US: Pharmaceuticals & Biotechnology

  • Back to Basics: 505(b)(2) FAQs Part 3: Regulatory Strategies (The 505(b)(2) Blog)
  • Opinion: The Myth Of The Post-Antibiotic Era (Forbes)
  • HHS: Freedom of Information Regulations (Federal Register)
  • What are the odds that your medication will help you get better? (STAT)
  • Long-Acting Opioids Carry Higher Risk of Death (Medpage)
  • Dr. Philip Majerus, Among the First to Discern Aspirin's Heart Benefits, Dies at 79 (NYTimes)
  • Be A Champion for Clinical Trial Diversity (FDA Voice)
  • Embattled Cambridge drugmaker Aegerion to merge with Canadian biotech (Boston Biz Journal)
  • UNC Geneticist Comments on Testing Laboratories' Duty to Return Genomic Data to Patients (Genomics Law Report)
  • ED drugs unlikely to increase malignant melanoma risk (OnMedica)
  • Antibiotics Against Severe Salmonella Infections in Africa are Increasingly Ineffective (ICT)
  • OTC Drug Regulatory Paradigm Open to Stakeholder Feedback Until July 10 (National Law Review)
  • Nemus licenses synthetic cannabinoid production tech from Teewinot (In-PharmaTechnologist)
  • Allergan takes its female empowerment message where pharma rarely goes: tank tops (Fierce)
  • CEO Joseph Papa Calls Valeant Pharmaceuticals a 'Distracted Organization' (The Street)

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

  • Lilly's Jardiance slows kidney disease progression in diabetics (Reuters) (Press)
  • Sobi says US FDA approves higher dose of Orfadin to treat rare genetic disorder (PharmaFile)
  • Merck Highlights Ongoing Commitment to Fighting Infectious Diseases with More than 30 Data Presentations at ASM Microbe 2016 (Press)
  • Insulet touts new data showing reduced A1c levels with Omnipod system | American Diabetes Assn. 2016 Scientific Sessions (MassDevice)
  • Hansa Medical: Successful Desensitization with IdeS in All Recruited Patients in Ongoing US Phase II Study (Press)
  • Flex Pharma Initiates Phase 2 Efficacy Study in Multiple Sclerosis (Press)
  • Soterix Medical Inc. Awarded $2.5M NIH Grant to Run Phase-2 Efficacy Trial to Treat Aphasia After Stroke with HD-tDCS. (Press)
  • Noveome Initiates Phase 2 Clinical Trial of ST266 to Treat Patients with Periodontitis (Press)
  • Shire and Kamada Announce FDA Approval of Expanded Label for Self-infusion of GLASSIA for the Treatment of Emphysema Due To Severe AAT Deficiency (Press)
  • FDA Grants Fanapt Three Years of Marketing Exclusivity for Labeling Changes Relating to Maintenance Treatment of Schizophrenia (Press)
  • Therapix Biosciences Filed an Application with the FDA to Approve an "Orphan" Designation for the Drug Developed Based on the Entourage Technology for Treating Tourette's Syndrome (Press)
  • CMC Biologics Cleared for Commercial Manufacture of CSL Behring's FDA-Approved AFSTYLA (Press)

US: Medical Devices

  • Medtronic gets closer to an artificial pancreas (EP Vantage)
  • FDA Issues Draft Guidance Regarding Dissemination of Patient Information from Medical Devices (FDA Law Blog)
  • Titan Spine touts implant warranty program (MassDevice)
  • Abbott touts clinical trial of its wearable glucose monitor at ADA (MassDevice)
  • Allergan Announces FDA Acceptance of the 510(k) Premarket Notification Filing for the XEN Glaucoma Treatment System (Press)
  • Tyber Medical Expands FDA 510(k) Clearance Of Headed And Snap-Off Screws (Press)
  • Lombard touts 5-year Aorfix stent graft data (MassDevice)

US: Assorted & Government

  • Medtronic Ruling Can Steer Transfer Pricing Tax Disputes (Law360-$)
  • Obamacare benchmark premiums to rise 10 percent, early data show (Politico)
  • Speaking at AMA, Slavitt makes his case for MACRA (Politico)
  • US Weighs In On 1st Circ. Appeal Of Covidien FCA Suit (Law360-$)
  • Zimmer Biomet breached deferred prosecution deal, U.S. says (MassDevice)

Upcoming Meetings & Events

Europe

  • NICE backs use of Boston Scientific laser therapy for outpatient enlarged prostate treatment (Fierce)
  • BMJ calls for the UK to remain in the European Union (OnMedica)
  • New EU Rules On Reprocessing To Put Heavy Burden On Resistant Commission (Clinica-$)
  • Sanofi releases real world data on Toujeo in diabetes (PharmaLetter)
  • NICE scrutinises community pharmacy's role in health promotion (Pharmaceutical Journal-$)
  • Man jailed for money laundering and importing and selling unlicensed medicines (MHRA)
  • GlaxoSmithKline's R&D Digital Evolution: An Interview With Senior VP Paul-Peter Tak (Geeks Talk Clinical)
  • Technology, not capacity, driving Catalent's biologics strategy (BioPharma-Reporter)
  • Vela Diagnostics NGS HCV Assay Receives CE Mark (GenomeWeb)
  • European CSRs Must Go Beyond the Realms of Cost Containment and Fiscal Sustainability (EFPIA)
  • Actelion says blood pressure drug Uptravi now available in Germany (Pharmafile)
  • Israeli startup BlueWind wins CE Mark for tiny, batteryless overactive bladder neurostimulator (Fierce)

Asia

  • TaiGen Biotech gains approval from China's FDA for Taigexyn (PharmaLetter-$)
  • Milner Therapeutics inducts Japan's Shionogi as consortium partner (BioSpectrum)
  • Acucela terminates Emixustat, OPA-6566 agreement with Otsuka Pharmaceutical (BioSpectrum)

India

  • Pharmexcil to compile document on India's pharma exports to Europe in next 4 yrs (Pharmabiz)
  • US FDA may embark on audit of nutraceutical cos in India to assess compliance with FDA 101 norms (Pharmabiz)
  • Zydus group inks pact with Eczacibasi to market biotech products (Economic Times)

Canada

Zika

  • WHO statement on the third meeting of the International Health Regulations (2005) (IHR(2005)) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations (WHO)
  • WHO sees 'very low' risk of further Zika spread due to Olympics (Reuters)
  • El Salvador says confirms first case of microcephaly linked to Zika (Reuters)

Other International

  • Ax falls on 33% of Chiasma staff after trial design doubts scuttle approval hopes (Fierce)

General Health& Other Interesting Articles

  • World Health Organization to Drop Coffee's Status as Possible Carcinogen (WSJ-$)
  • Most women with pregnancy-related diabetes don't get timely screening later (Reuters)

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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