Regulatory Focus™ > News Articles > Regulatory Recon: FDA Offers New Details on its Breakthrough Product Designation Program (30 July 20

Regulatory Recon: FDA Offers New Details on its Breakthrough Product Designation Program (30 July 2014)

Posted 30 July 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Offers New Details on its Breakthrough Product Designation Program (30 July 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s 2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.  Register by 29 August 2014 to receive the lowest rate.

In Focus: US

  • ‘Breakthrough’ Drugs Get ‘Road-MaPP’ – Complete With Communication Timetable (Pink Sheet-$) (FDA)
  • FDA Approves Regeneron's Eylea (Pharma Times) (SCRIP-$) (MedCity News) (Press) (Reuters)
  • Sarepto Strips CEO of Authority to Represent it in Negotiations With FDA (WSJ-$) (BioFlash) (Fierce)
  • Is FDA ‘Buried’ Under a Backlog of Generic Drug Applications? (Pharmalot)
  • Software Risk Should Drive Regulation, AAMI, AdvaMed Say (Gray Sheet-$)
  • AdvaMed: Expedited PMA Device Pathway Should Apply To 510(k)s (IHP-$)
  • Why Are Dope-addicted, Disgraced Doctors Running Our Drug Trials? (Medium)
  • The Low Down on the Quality of Dietary Supplements (USP)
  • Researchers Fret as Social Media Lift Veil on Drug Trials (WSJ-$)

In Focus: International

  • CDSCO to launch IT-enabled system for online submission of information on clinical trials (PharmaBiz)
  • Russia tightens responsibility for sale and production of counterfeit drugs (Pharma Letter-$)
  • Bayer's Stivarge Approved in EU for Treatment of Gastrointestinal Stromal Tumors (Press)
  • CHMP Issues Positive Opinion for Merck’s Noxafil IV (Press)
  • EU expands use of Pfizer/B-MS bloodthinner Eliquis (Pharma Times)

US: Pharmaceuticals and Biotechnology

  • ‘Breakthrough’ Drugs Get ‘Road-MaPP’ – Complete With Communication Timetable (Pink Sheet-$) (FDA)
  • FDA Approves Regeneron's Eylea (Pharma Times) (SCRIP-$) (MedCity News) (Press) (Reuters)
  • OTC Benzocaine Needs Label Warning, Indication Change – Public Citizen (Tan Sheet-$) (Public Citizen)
  • Sarepto Strips CEO of Authority to Represent it in Negotiations With FDA (WSJ-$) (BioFlash) (Fierce)
  • Is FDA ‘Buried’ Under a Backlog of Generic Drug Applications? (Pharmalot)
  • FDA’s “Breakthrough” Evolves: What’s Next For The Popular Program? (RPM Report-$)
  • Water Systems in FDA Warning Letters (ECA)
  • Could Impax's FDA Form 483 Affect its Investigative Parkinson's Drug Rytary? (Fierce) (Reuters)
  • FDA Talks Up Continuous Manufacturing, Offers Assistance (Gold Sheet-$)
  • FDA Responds to DMD Petition (White House)
  • FDA Faced Resistance As It Pursued Recall At Registered Compounding Facility (IHP-$)
  • California Pharmacists Resist Translating Medicine Labels (NPR)
  • Pharmacy Software Company Might Be Liable for Side-Effect (National Law Journal)
  • Hospira Recalls of Lot of Lidocaine HCl Over Particulate Matter (FDA)
  • Ranbaxy in Settlement Discussion With US—but for What? (SCRIP-$)
  • FDA Clears Ampio CMC Plan to Manufacture Ampion (Press)
  • FedEx Denies It Illegally Distributed Generic Valium, Xanax (Law 360-$)

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

  • Sanofi, Regeneron drug cuts cholesterol in nine late-stage trials (Reuters) (Bloomberg)
  • GSK Malaria Vaccine Data Shows Efficacy in Young Children (PLoS)
  • Vertex discloses Phase II CF miss (BioCentury)
  • FDA Accepts for Review Adamis' New Drug Application for Its Epinephrine Pre-Filled Syringe (Press)

US: Pharmaceuticals and Biotechnology: General

  • PCORI Board Approves $54.8 Million in Funding for Patient-Centered Comparative Effectiveness Research Projects (PCORI) (BioCentury)
  • Optimal Aspirin Dose for Patients with Coronary Artery Disease Approved as Topic for First PCORnet Research Trial (PCORI)
  • House Approves Legislation to Combat Prescription Drug Abuse (Press) (Bill) (The Hill) (Law 360-$)
  • Controlling The Light Switch: PhRMA Wants Chance To Shape Context Of Sunshine Act’s Data (Pink Sheet-$) (CHC)
  • HHS: O-Care saved billions in drug costs (The Hill)
  • OIG Issues Favorable Advisory Opinion on Drug Manufacturer’s Direct-To Patient Discounted Drug Sales Program (FDA Law Blog)
  • DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 3 (RxTrace)
  • Monitoring prescription drugs in Maine: ten years later (NECIR)

US: Medical Devices

  • These Medical Apps Have Doctors and the FDA Worried (Wired)
  • Software Risk Should Drive Regulation, AAMI, AdvaMed Say (Gray Sheet-$)
  • AdvaMed: Expedited PMA Device Pathway Should Apply To 510(k)s (IHP-$)
  • FDA Tips On MDRs, Complaints, Other Hot Topics (Silver Sheet-$)
  • Breaches in Supply Chain Security Increase Regulatory Scrutiny of Raw Materials Used in Medical Devices (PDD)
  • Bard settles more than 500 pelvic mesh complaints (Mass Device)
  • Boston Scientific Wins First Pelvic Mesh Injury Trial (Law 360-$) (Bloomberg)
  • Bogus medical devices make their way into trade shows (Dermatology Times)
  • Wellspring Pharma Recalls IPM Wound Gel Due to Potential Microbial Contamination (FDA)
  • FDA clears molecular diagnostic strep throat test by Quidel (MedCity News)
  • Mauna Kea Technologies Receives 510(K) Regulatory Clearance from U.S. FDA for New Cellvizio System Functioning in a near-Infrared Wavelength (Press)
  • Cynosure Announces PicoSure Is FDA-Cleared To Treat Acne Scars (Press)

US: Dietary Supplements

  • The Low Down on the Quality of Dietary Supplements (USP)
  • 5 Tips to Avoid Adulterated Products Marketed as Dietary Supplements (USP)
  • Do Dietary Supplements Enhance Athletic Performance? (USP)

US: Assorted And Government

  • Why Are Dope-addicted, Disgraced Doctors Running Our Drug Trials? (Medium)
  • FDA Touts IT Improvements (FDA)
  • FDA Approves First Artificial Tumor (The Onion-Humor)

Europe

  • Bayer's Stivarge Approved in EU for Treatment of Gastrointestinal Stromal Tumors (Press)
  • CHMP Issues Positive Opinion for Intravenous (IV) Formulation of Merck’s NOXAFIL (posaconazole) (Press)
  • EU expands use of Pfizer/B-MS bloodthinner Eliquis (Pharma Times)
  • U.K Drug-Repurposing Program Expands, Attracts Industry Support (Pink Sheet-$)
  • PlaqueTec gets CE mark for device that collects blood samples from the coronary artery (MedCity News)

India

  • CDSCO to launch IT-enabled system for online submission of information on clinical trials (PharmaBiz)
  • IPA president optimistic of robust regulatory landscape with Centre's fund allocation of Rs.1,750 cr (PharmaBiz)
  • Indian Drug Makers Need a Cure for Their Profit Problems (WSJ-$)

Canada

Australia

  • Vertex Still Not Available to Australian Consumers (BioCentury)

Other International

  • Russia tightens responsibility for sale and production of counterfeit drugs (Pharma Letter-$)
  • The Fight Against Fake Birth Control (PopSci)

Clinical Trials

  • Why Are Dope-addicted, Disgraced Doctors Running Our Drug Trials? (Medium)
  • Researchers Fret as Social Media Lift Veil on Drug Trials (WSJ-$)

General Regulatory And Interesting Articles

  • 'No Market': Scientists Struggle to Make Ebola Vaccines, Treatments (NBC)
  • Do We Have Any Drugs To Treat Ebola? (Forbes) (SciAm)
  • When Companies Care About What you Say About Their Drug Study on Twitter: A Case Study (Press)

Regulatory Reconnaissance #368 – 30 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.

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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