Regulatory Focus™ > News Articles > Regulatory Recon: EMA Trial Transparency Initiative Put on Hold (10 July 2014)

Regulatory Recon: EMA Trial Transparency Initiative Put on Hold (10 July 2014)

Posted 10 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: EMA Trial Transparency Initiative Put on Hold (10 July 2014)

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In Focus: US

  • FDA Clinical Trials Need More Flexibility, Lawmakers Say (Law 360-$) (BioCentury) (SCRIP-$) (E&C) (Pink Sheet-$)
  • FDASIA Turns Two; FDA Says Deliverables On-Track (FDA)
  • FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules (WaPo)
  • Why the first GAIN Act antibacterial drug is underwhelming (TIE)
  • FDA’s Device Center Looks To Risk Management As It Pens Quality-Related Inspectional Guidance (Silver Sheet-$)
  • Light touch regulatory scheme seems likely for HIT (Modern Healthcare-$)
  • Consistency and Standardization of Color in Medical Imaging: a Consensus Report (PubMed)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • FDA Clinical Trials Need More Flexibility, Lawmakers Say (Law 360-$) (BioCentury) (SCRIP-$) (E&C) (Pink Sheet-$)
  • FDASIA Turns Two; FDA Says Deliverables On-Track (FDA)
  • FDA has free-speech, safety issues to weigh in review of ‘off-label’ drug marketing rules (WaPo)
  • Why the first GAIN Act antibacterial drug is underwhelming (TIE)
  • Review of ADHD Drug Approvals Highlights Gaps between Pediatric Approval Process and Long-Term Safety Assessment (Press) (PubMed)
  • With Briefing Nearly Complete, Folks Get Set to Hunker Down for High-Stakes Rulings in Challenges to BPCIA Biosimilars “Patent Dance” Procedures (FDA Law Blog)
  • Pharmaceutical detailing and the off-label use of psychotherapeutic medications with children (TIE)
  • Sanofi ups the legal ante to block Lilly's Lantus biosimilar (Fierce) (Reuters)
  • The Food and Drug Administration Advisory Committees and Panels: How They Are Applied to the Drug Regulatory Process (PubMed)
  • Of human-on-a-chip and humans: Considerations for creating and using microphysiological systems (PubMed)
  • Pfizer Petitions for Five Years of NCE Exclusivity (FDA)
  • GRAS always greener? FDA considers overhauling OTC monograph system (In-Pharma)
  • Doctors Urge End Of 'Black Box' Warning On Antidepressants (ABC)

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

  • Sanofi/Regeneron's dupilumab succeeds for skin disorder (Pharma Times) (NYTimes) (BioCentury) (Reuters)
  • Regado Biosciences announces FDA’s clinical hold of Ph III trial (Pharma Letter-$) (SCRIP-$)
  • Latest Sarepta Study Update Shows Greater Decline in Walking Ability (The Street) (Forbes) (Press) (Fierce)
  • Astellas submits NDA for isavuconazole to treat deadly fungal infections (Pharma Letter-$) (Press) (BioCentury)
  • Novartis announces NEJM publication of two phase III studies demonstrating high efficacy of secukinumab (AIN457) in psoriasis patients (Press)
  • TransTech Pharma, LLC Announces Agreement with FDA on Special Protocol Assessment for TTP488 Phase 3 Trial in Patients with Mild Alzheimer’s Disease (Press)
  • Bristol-Myers races to the FDA with immuno-oncology star nivolumab  (Fierce) (Press)
  • Insys Updates Timing of NDA for Dronabinol Oral Solution (Press)

US: Pharmaceuticals and Biotechnology: General

  • GlycoVaxyn Trialing New Vaccine Technology For Recurrent UTIs, Shigella (Pink Sheet-$)
  • Opioid Abuse major focus of new WH drug strategy (The Hill)
  • Study: Psychiatric Drug ER Trips Approach 90,000 a Year (AP)

US: Medical Devices

  • FDA’s Device Center Looks To Risk Management As It Pens Quality-Related Inspectional Guidance (Silver Sheet-$)
  • Light touch regulatory scheme seems likely for HIT (Modern Healthcare-$)
  • Consistency and Standardization of Color in Medical Imaging: a Consensus Report (PubMed)
  • UDI: What Do Manufacturers Need to Do? (MDS)
  • FDA flags Zynex Medical over chronic pain devices (Mass Device)
  • SomnoMed Receives 510(K) Clearance for SomnoDent Fusion (Press)
  • Quantel Medical's Optimis Fusion Receives FDA 510(k) Clearance (Press)
  • Lawsuits Say Calif. Doctors Used Unapproved Screws in Surgeries (CA Healthline)

US: Dietary Supplements

  • FDA Tainted Supplement War Finds More Violations Yearly From 2011 (Tan Sheet-$)
  • United States enters consent decree with New York dietary supplement manufacturer (FDA)

US: Assorted And Government

Europe

India

  • India faces higher QC costs as Shasun shows value of compliance (Fierce)
  • India Debates Stronger Microbial Contamination Standards (PharmaBiz)

China

Canada

  • Most Canadian prescription labels fail to meet guidelines, risking dosage errors (Press) (CBC)
  • Health Canada's quiet move to end use of antibiotics to fatten up animals (CBC)

Other International

  • Phillipines FDA Warns of Fraud Using its Name (Inquirer)
  • Novartis Launches Novel Malaria Drug In Kenya As Fewer-Dose Treatment (Pink Sheet-$)

Clinical Trials

General Regulatory And Interesting Articles

  • Global antibiotic consumption soars 36% in 10 years, raising concerns about superbugs (CDDEP) (NPR)
  • Asthma inhaler lodged in chest highlights importance of warning labels (Reuters)
  • Vaccine Achieves Simultaneous Protection Against Ricin, Anthrax (Press)

Regulatory Reconnaissance #354 – 10 July 2014

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

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.


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