Regulatory Focus™ > News Articles > Regulatory Recon: How a Killer Pharmacy Led to Compounding Changes at FDA (22 April 2015)

Regulatory Recon: How a Killer Pharmacy Led to Compounding Changes at FDA (22 April 2015)

Posted 22 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: How a Killer Pharmacy Led to Compounding Changes at FDA (22 April 2015)

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

In Focus: US

In Focus: International

  • EMA provides advice notes on pharmacovigilance annual fees (EMA)
  • Concept paper on the development of a guideline on quality and equivalence of topical products (EMA)
  • Improving market conditions in the US for EU device manufacturers: TTIP meeting (Clinica-$)
  • Indian parliamentary committee recommends price caps for all drugs (Reuters) (Fierce)
  • Understaffed CFDA at the Root of 18,000-Application Backlog, Delays to Market (Thompson Reuters)
  • A Groupon for Fake Condoms (TGA) (Herald Sun)

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US: Pharmaceuticals and Biotechnology

  • Killer Pharmacy: Inside a Medical Mass Murder Case (Newsweek)
  • Breakthrough therapy designation: A primer (Brookings)
  • Neurologists Back FDA on Call for ALS Drug Data (MedPage Today)
  • Pharmaceutical Industry Rallies Against California Drug Pricing Transparency Bill (Press)
  • FDA Opens Comment Docket on its PDUFA Performance (FDA)
  • Oxytocin Products Can be Marketed as Generics, FDA Says (FDA)
  • Texas House Passes Right to Try Bill (AP)
  • Innovations in Medical Countermeasure Continuous Manufacturing (FDA)

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

  • Following a setback, Pfizer gets a win in Phase III cancer drug study (Fierce)
  • AstraZeneca drug Lynparza shows promise in prostate cancer trial (Reuters) (SCRIP-$)
  • Pfizer Receives U.S. FDA Breakthrough Therapy Designation For XALKORI (crizotinib) (Press)
  • Cantrixil Receives Orphan Drug Designation from FDA (Press)
  • Capricor Granted FDA Orphan Drug Designation for Allogeneic Cardiosphere-Derived Cells for the Treatment of Duchenne Muscular Dystrophy (Press)
  • SolaranRx’s SRX-1177 Receives FDA Orphan Drug Designation as Malignant Melanoma Treatment (Press)

US: Pharmaceuticals and Biotechnology: General

  • Soaring Drug Prices May Be the Next Big Thing for 2016 Contenders (National Journal)
  • Teva bids $40.1B for Mylan (BioCentury) (Reuters)
  • New PhRMA industry profile reports 7,000 medicines currently in development (DSN) (Report)
  • House Approves Key Bill to Combat Prescription Drug Abuse (E&C) (Law 360-$)
  • Bass now targeting Imbruvica patent (BioCentury) (Fierce)

US: Medical Devices

  • Endoscope Maker Warned Europe Two Years Before Calif. Outbreaks (CA Healthline) (LATimes)
  • Data and Technology: Keys to Precision Medicine and 21st Century Cures (Manhattan Institute)
  • Patel Cautions Against "Unintended Consequences" of mHealth Legislation (Gray Sheet-$)
  • Sunshine Heart can resume trial after FDA OKs 'minor' changes (MassDevice)
  • FDA Accepts Rolling PMA for Spectral Medical's Septic Shock Device (Press)
  • Syneron Candela's PicoWay Picosecond Laser Receives U.S. FDA Clearance For Treatment Of Pigmented Lesions (Press)
  • Alcyone Lifesciences Receives FDA Clearance for MRI-Compatible MEMS Cannula (Press)
  • Great Basin Receives FDA 510(k) Clearance for Group B Strep Molecular Diagnostic Test (Press)

US: Dietary Supplements

  • CFSAN ‘Culture’ Could Change With Director Mayne’s Staff Decisions (Tan Sheet-$)
  • FDA: Safety problems prompted review of homeopathic remedies (AP) (KQED) (Law 360-$) (MedPage Today) (NPI)

US: Assorted And Government

  • FDA Hoping To Shift Some ‘Cures’ Initiatives Toward User Fee Negotiations (Pink Sheet-$)
  • Michele Leonhart, Head of D.E.A., to Retire Over Handling of Sex Scandal (NYTimes)
  • Should NIH's Budget be Doubled? (NYTimes)

Upcoming Meetings and Events

Europe

  • EMA provides advice notes on pharmacovigilance annual fees (EMA)
  • Concept paper on the development of a guideline on quality and equivalence of topical products (EMA)
  • Improving market conditions in the US for EU device manufacturers: TTIP meeting (Clinica-$)
  • UK Woman dies from toxic diet pills bought online (CBS)
  • Classification of Medicines - 2014 Edition of Resolution ResAP(2007)1 now available (EDQM)

India

  • Indian parliamentary committee recommends price caps for all drugs (Reuters) (Fierce)
  • Commerce ministry to meet stakeholders next week to discuss issues over track & trace system (PharmaBiz)

China

  • Understaffed CFDA at the Root of 18,000-Application Backlog, Delays to Market (Thompson Reuters)
  • China steps up decentralized drug industry regulation, market prices push (Fierce)

Australia

General Regulatory And Interesting Articles

Regulatory Reconnaissance #541 – 22 April 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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