Regulatory Focus™ > News Articles > Regulatory Recon: FDA Creating New Disease Awareness Advertising Guidance (14 May 2015)

Regulatory Recon: FDA Creating New Disease Awareness Advertising Guidance (14 May 2015)

Posted 14 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA Creating New Disease Awareness Advertising Guidance (14 May 2015)

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

In Focus: US

  • FDA Crafting New Disease Awareness Draft Guidance (Thompson's-$) (RegulatoryRx)
  • More on FDA's Recent Trio of Biosimilars Guidance Documents (FDA Law Blog)
  • Who Should Get 'Compassionate Use' Drugs? (Medscape)
  • Analyst: Patients were key to Vertex panel recommendation (BioFlash)
  • LDT Regulation Overhaul Left out of 21st Century Cures Act (IHP-$)
  • Upcoming FDA Workshop on Partial Gland Ablation for Prostate Cancer (FDA)
  • A clinician’s perspective: The value of medical device surveillance (Brookings)
  • FDA Gains Cures Funding In Latest 21st Century Cures Draft (Pink Sheet-$)
  • Bureaucrats Adopting The Tech Tools Of Silicon Valley (538)

In Focus: International

  • Multibillion-Dollar Investment Needed to Fight Drug-Resistant ‘Superbugs’ (WSJ-$) (FT-$) (TIE) (Pharmafile) (PharmaTimes) (SCRIP-$)
  • European Regulations Preventing Lift-off for Advanced Therapies? (Thompson Reuters)
  • HTA Network Reflection Paper On “Reuse Of Joint Work In National Hta Activities” (EUnetHTA)

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US: Pharmaceuticals and Biotechnology

  • FDA Crafting New Disease Awareness Draft Guidance (Thompson's-$) (RegulatoryRx)
  • More on FDA's Recent Trio of Biosimilars Guidance Documents (FDA Law Blog)
  • Who Should Get 'Compassionate Use' Drugs? (Medscape)
  • Fibrocell Science Stock Spikes Following Rare Pediatric Disease Treatment Designation (The Street)
  • Analyst: Patients were key to Vertex panel recommendation (BioFlash)
  • FDA Advisory Committee to Discuss Communication of Fetal Effects of Methadone or Buprenorphine for Opioid Addiction (Tarius)
  • Will Patient-Reported Outcomes Be Included in Oncology Product Labeling? (Cancer Therapy Advisor)
  • FDA Advisory Committee Reviews Blood Tests and Hears Presentations About Hematology Research and the Donor Deferral Policy for Gay Men (Tarius)
  • Study investigates the quality of organs from potential donors with HIV (Press)
  • Wockhardt recalls 93K bottles of Captopril tablets from US (IndiaTimes)
  • Nestle Health Science Says Competitor's Generic Is Fake (Law 360-$)
  • NIAID: Study participants exposed to tainted HIV vaccine (SCRIP-$)
  • Public Citizen Chides OHRP for Not Investigating University of Minnesota Over Drug Trial (PC)
  • NIH Translational Science Center Gets Expanded Powers In Cures Bill (Pink Sheet-$)

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

  • Roche moves closer to US filing for alectinib (PMLive) (Press)
  • Roche immunotherapy improves lung cancer survival (Reuters) (Press)
  • Bristol, AbbVie drug extends multiple myeloma remission: study (Reuters) (WSJ-$) (The Street) (BioCentury)
  • Bavarian Nordic smallpox vaccine meets in two trials (BioCentury) (MNT)
  • Takeda discontinues alisertib trial (BioCentury)
  • Puma down on Phase III neratinib data (BioCentury)
  • AstraZeneca drug combination on track to fight lung cancer (Reuters)
  • 10 Important Checkpoint Inhibitor Cancer Drug Abstracts from ASCO '15 (The Street)
  • Sage steps up to a pivotal PhIII as brain seizure drug aces trial challenge (Fierce)
  • Personalized approach helped cure more children with kidney cancer (Reuters)
  • Heron Therapeutics to Use 505(b)(2) Pathway for its Drug, HTX-019 (Press)

US: Pharmaceuticals and Biotechnology: General

  • NEJM Takes a Closer Look at the Tufts Study on the Costs of Drug Development (NEJM)

US: Medical Devices

  • LDT Regulation Overhaul Left out of 21st Century Cures Act (IHP-$)
  • Upcoming FDA Workshop on Partial Gland Ablation for Prostate Cancer (FDA)
  • A clinician’s perspective: The value of medical device surveillance (Brookings)
  • ResMed down 15% as sleep apnea device fails in Phase III cardio trial (Fierce)
  • Philips quality improvement plan hit by recall at its troubled Cleveland facility (Fierce)
  • Biologic Therapies Receives 510(k) Clearance for Bio-MAC and Bio-CORE Bone Marrow Aspiration Cannulas (Press)
  • PENTAX Medical Reaffirms Commitment to Work with FDA and Industry Partners To Address Duodenoscope Infection Issues (Press)
  • 17M women could lose breast cancer screening guarantee (CNBC)

US: Dietary Supplements

  • NJ Legislature considers outlawing powdered caffeine (AP)
  • Supplement industry split over NY AG DNA barcode testing (DSN)
  • FTC charges Lunada with misleading weight loss claims (NewHope360)
  • FTC Challenges Marketers’ Baseless Claims That Their Supplements Prevent or Reverse Gray Hair (FTC)

US: Assorted And Government

  • FDA Gains Cures Funding In Latest 21st Century Cures Draft (Pink Sheet-$)
  • FDA Inspections by the Numbers (FDAzilla)
  • Some Washington Bureaucrats Are Adopting The Tech Tools Of Silicon Valley (538)
  • Senate May Delay ‘Cures' Vote to Fall, Behind House Goal of Summer Floor Vote (BNA)
  • FDAzilla Launches New Inspection/Enforcement Analytics Tool (FDAzilla)
  • Department of Justice Announces New Acting Administrator of Drug Enforcement Administration (DOJ)
  • FDA's Weekly Enforcement Report (FDA)

Upcoming Meetings and Events

Ebola Outbreak

Europe

  • Multibillion-Dollar Investment Needed to Fight Drug-Resistant ‘Superbugs’ (WSJ-$) (FT-$) (TIE) (Pharmafile) (PharmaTimes) (SCRIP-$)
  • European Regulations Preventing Lift-off for Advanced Therapies? (Thompson Reuters)
  • HTA Network Reflection Paper On “Reuse Of Joint Work In National Hta Activities” (EUnetHTA)
  • St. Jude Medical expands CE Mark approval for Ellipse ICD (MassDevice)
  • Renal denervation: Ablative Solutions wins CE Mark for chemical ablation catheter (MassDevice)
  • Therabron's CG100 gets EMA orphan drug status to prevent bronchopulmonary dysplasia (PBR)

India

  • Jan Aushadhi stores to be relaunched with drugs for lifestyle diseases from June (PharmaBiz)

Canada

  • Safety Review Finds Sevorane AF May Cause Severe Low Heart Rate in Children With Down Syndrome (HC)

General Regulatory And Interesting Articles

  • Vitamin Pill Cuts Skin Cancer Risk (NBC)
  • Grip Strength May Predict Heart Attacks and Strokes (NYTimes)

Regulatory Reconnaissance #557 – 14 May 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 @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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