Regulatory Focus™ > News Articles > Regulatory Recon: Is NASA Looking at the Drug Distribution Game? (20 July 2015)

Regulatory Recon: Is NASA Looking at the Drug Distribution Game? (20 July 2015)

Posted 20 July 2015 | By Michael Mezher 

Regulatory Recon: Is NASA Looking at the Drug Distribution Game? (20 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

  • Flirtey and NASA Complete First US-Approved Drone Delivery (The Hill) (In-Pharma Technologist) (medGadget) (NASA)
  • NY Times op-ed slams 21st Century Cures Act (MassDevice) (NYTimes)
  • How not to Fix the FDA (NYTimes)
  • Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry (Federal Register)
  • Big pharma's future: panel discussion (SCRIP-$)
  • Inside FDA Regulation of Antibody Drug Conjugates (Law360-$)
  • Market Claims in Direct-to-Consumer Prescription Drug Print Ads, Comment Request (Federal Register)
  • PDUFA VI: Biosimilar Meetings Could Be Model for Earlier User Fee Payments (Pink Sheet-$) (SCRIP-$)
  • Biosimilars Provision in Pacific Trade Deal Adds Fuel to Generic Fight (Pink Sheet-$) (Law360-$)
  • Opinion: 'Cures' Act Will Change Lives for the Better (The Hill)

In Focus: International

  • Pharmacovigilance Risk Assessment Committee confirms Chair and Vice-chair for new three year mandate (EMA)
  • Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage form (EMA)
  • Podcast: Medical Device Distribution in Europe (Emergo)
  • Pharma must ‘create new social contract’ (PMLive)
  • Understanding the Dynamics of China’s Medicine Regulatory Environment (Thomson Reuters)
  • China FDA issues final classification rules on medical devices (FiercePharmaAsia)
  • WHO issues draft norms for surveys to assess drug quality & efficacy of medicines (PharmaBiz)
  • Ethiopia debuts 10-year strategy and plan to increase access to medicines (PharmaLetter-$)
  • Novartis malaria treatment Coartem receives WHO prequalification (PharmaAfrica)

US: Pharmaceuticals and Biotechnology

  • Flirtey and NASA Complete First US-Approved Drone Delivery (The Hill) (In-Pharma Technologist) (medGadget) (NASA)
  • Bioequivalence Recommendations for Lubiprostone; Revised Draft Guidance for Industry (Federal Register)
  • Big pharma's future: panel discussion (SCRIP-$)
  • Inside FDA Regulation Of Antibody Drug Conjugates (Law360-$)
  • Determination That TESSALON (Benzonatate) Capsules and Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness (Federal Register)
  • Ahead of Alzheimer’s meeting, researchers seize on signs of progress (Reuters)
  • Teva First to Win FDA Nod for Generic Axert (FDANews)
  • Podcast: Look Ahead To PCSK9 Inhibitors (Pink Sheet-$)
  • Hospira receives FDA approval for generic of The Medicines Company's Angiomax (PharmaLetter-$)

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

  • Amgen's latest immuno-oncology drug comes through in Phase II (FierceBiotech) (PMLive)
  • Efficacy, Costs for Rivaroxaban vs. Standard of Care (MPR)
  • Heron Therapeutics Resubmits SUSTOL New Drug Application to FDA (Press)
  • Phase III Opdivo Renal Cell Cancer Trial Stopped Early After Meeting Endpoint (Press)
  • AbbVie anti-tau drug granted orphan status (PMLive) (PharmaLetter-$)
  • Recro's Dex-IN meets in Phase II pain study (BioCentury)
  • Amgen Lauds Positive Phase II Data for Leukemia Drug Blincyto (BioSpace)
  • Delcath Receives Orphan Drug Designation From FDA For Melphalan To Treat Cholangiocarcinoma (Press)
  • Alnylam Starts Phase 3 Study on Investigational RNAi Therapeutic Targeting Transthyretin (TTR) for the Treatment of TTR-Mediated Amyloidosis (Press)
  • Exelixis Announces Positive Results from Phase 3 Trial of Cabozantinib vs. Everolimus for Metastatic Renal Cell Carcinoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Market Claims in Direct-to-Consumer Prescription Drug Print Ads, Comment Request (Federal Register)
  • PDUFA VI: Biosimilar Meetings Could Be Model For Earlier User Fee Payments (Pink Sheet-$) (SCRIP-$)
  • Biosimilars Provision In Pacific Trade Deal Adds Fuel To Generic Fight (Pink Sheet-$) (Law360-$)
  • Congressional leaders have four reasons why TPP is bad for generic access (DSN)
  • Initial Break-Out of Senate Ag/FDA Committee FY 16 Appropriation (StrengthenFDA.org)
  • GPhA criticizes FDA for GDUFA delays (DSN)
  • The State of Drug Safety Systems (RxViewBlog)
  • Opinion: 'Cures' Act Will Change Lives for the Better (The Hill)
  • FDA and Manufacturers Map Out PDUFA Reform Priorities (PharmTech)
  • FDA Reverses Debarment of David Brancato for Providing Substantial Assistance in an Investigation (FDA)

US: Medical Devices

  • Wearable gizmos vs. medical devices: how companies can comply with FDA security recommendations (Lexology)
  • Startup begins major trial for duodenal resurfacing to treat Type 2 diabetes (FierceMedicalDevices)
  • Egg whites: A material of the future in med tech? (FierceMedicalDevices)
  • New limb-lengthening technique is less cumbersome for patients (MNT)
  • Thirty Percent of Medtech Patents are Awarded to International Applicants (MDDI)

US: Assorted and Government

  • Stakeholder Consultation Meetings on the Prescription Drug User Fee Act Reauthorization (Federal Register)
  • NY Times op-ed slams 21st Century Cures Act (MassDevice) (NYTimes)
  • How not to Fix the FDA (NYTimes)

Upcoming Meetings and Events

Europe

  • Pharmacovigilance Risk Assessment Committee confirms Chair and Vice-chair for new three year mandate (EMA)
  • Concept paper on the need for revision of the note of guidance on manufacture of the finished dosage form (EMA)
  • Recommendation to marketing authorisation holders, highlighting recent updates for reduction, refinement and replacement (3Rs) methods described in the European Pharmacopoeia (EMA)
  • Podcast: Medical Device Distribution in Europe (Emergo)
  • Pharma must ‘create new social contract’ (PMLive)
  • Advertising investigations: June 2015 (MHRA)
  • U.K. puts Cambridge at the heart of £50M precision medicine program (FierceBiotech)
  • NHS is ‘drowning in bureaucracy’, report into NHS management says (OnMedica)

India

  • Indian stentmakers gaining global foothold--is U.S. market next? (FierceMedicalDevices)
  • Gujarat FDCA Takes Action on Two Medical Device Makers (PharmaBiz)
  • Green GMP criteria would help responsible API firms compete with polluters (In-Pharma Technologist)
  • Pharmacist Association Wants Gov't to Define Role of Wholesalers in Price Control Order (PharmaBiz)
  • Gujarat FDCA to Ask Commerce Ministry to Release funds for Biocompatibility & Medical Device Testing Lab (PharmaBiz)
  • Several Bills Related to Health & Pharma Awaiting Vote as Parliament Session Begins (PharmaBiz)

China

  • Understanding the Dynamics of China’s Medicine Regulatory Environment (Thomson Reuters)
  • China FDA issues final classification rules on medical devices (FiercePharmaAsia)

Australia

  • Undeclared substance found in ActiveSlim slimming capsules (TGA)

Other International

  • Singapore's big biotech push yields its first clinical contender (FierceBiotech)
  • IMDRF SaMD Workgroup Survey on Software as a Medical Device and IVD Guidance (IMDRF)
  • WHO issues draft norms for surveys to assess drug quality & efficacy of medicines (PharmaBiz)
  • Ethiopia debuts 10-year strategy and plan to increase access to medicines (PharmaLetter-$)
  • Novartis malaria treatment Coartem receives WHO prequalification (PharmaAfrica)

General Regulatory and Interesting Articles

  • How Did A Medical Miracle Turn Into A Global Threat? (NPR)
  • Resistance isn’t futile – how to tackle drug-resistant superbugs (The Guardian)
  • Did reports of side effects contribute to drop in bone drug use? (Reuters)
  • Alzheimer’s scientists to meet in D.C. amid signs of progress for treatment (Washington Post)
  • Former opponents team up to cut drug costs (ModernHealthcare)

Regulatory Reconnaissance #599– 20 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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