Regulatory Focus™ > News Articles > Regulatory Recon: FDA Yanks Some Warning Letters off Website (21 January 2015)

Regulatory Recon: FDA Yanks Some Warning Letters off Website (21 January 2015)

Posted 21 January 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Yanks Some Warning Letters off Website (21 January 2015)

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

In Focus: US

In Focus: International

  • EMA Accepts Samsung Bioepis' Enbrel Biosimilar Candidate, SB4, for Regulatory Review (Press)
  • Novartis' Cosentyx cleared for psoriasis in Europe (PMLive) (EC) (Fierce)
  • EC on Harmonized Medical Device Standards (EC)
  • Italian police recover stolen medicines (Securing Industry)
  • Assistant Commissioner of Indian FDA Caught Taking Bribes (Business Standard) (IndiaTimes)
  • Inside India: The Deadly Effects of Red Tape on Drug Approvals (WSJ)
  • China’s lifting of online drug ban raises counterfeit concerns (Securing Industry)

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US: Pharmaceuticals and Biotechnology

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

  • Gedeon/Actavis's new cariprazine data enough in schizophrenia? (SCRIP-$)
  • J&J chief predicts 10 new pharma filings by 2017 (PMLive)
  • UCB Announces US and EU Regulatory Filings for the Investigational Antiepileptic Drug Brivaracetam (Press) (Pharmafile)
  • FDA Grants Fast Track Status for Celator’s CPX-351 to Treat Elderly Patients with Secondary AML (Press)
  • Actavis, Richter tout new PhIII data for their tarnished schizophrenia drug (Fierce)

US: Pharmaceuticals and Biotechnology: General

US: Medical Devices

  • LDT Industry Goes After FDA in Editorial (Roll Call)
  • FTC slaps video game maker over inaccurate claims (mHealthNews) (Reuters) (MobiHealthNews)
  • FDA wellness clarifications helpful, accessory proposal is just a start (MobiHealthNews)
  • Pew Submits Letter to Health and Human Services Regarding Unique Device Identifier Capture in Electronic Health Records (Pew)
  • FDA officially clears Integra's Puerto Rico plant (Mass Device)
  • Hospira Receives FDA Clearance for Plum 360 Infusion System (Press)
  • FDA Clears New Version of Digital Radiography System (Press)
  • FDA grants 510(k) clearance for OCT system, new software for Victus platform (Press)
  • NEC Display Solutions Receives FDA 510(K) Clearance on MD210C3 Diagnostic Review Monitor (Press)
  • Applied Spectral Imaging receives FDA Clearance for GenASIs HiPath IHC Family for HER2 ER PR and Ki67 (Press)

US: Dietary Supplements

  • FDA rule offers only narrow field for blood sugar management claims, experts say (NI-USA)
  • Too Little, Too Late: Ineffective Regulation of Dietary Supplements in the United States (PubMed)

US: Assorted And Government

  • Sen. Moran to chair spending panel for FDA (AgriPulse)

Upcoming Meetings

Ebola Outbreak

  • Mutant Ebola Virus May Evade Drugs, Study Finds (NBC)

Europe

  • Italian police recover stolen medicines (Securing Industry)
  • EMA Accepts Samsung Bioepis' Enbrel Biosimilar Candidate, SB4, for Regulatory Review (Press)
  • Novartis' Cosentyx cleared for psoriasis in Europe (PMLive) (EC) (Fierce)
  • EC on Harmonized Medical Device Standards (EC)
  • BPA plastics chemical poses no health risk, says European watchdog (Reuters)
  • Xarelto gets new atrial fibrillation label in Europe (PMLive)
  • Novo Nordisk's Victoza granted label extension in the UK (PharmaLetter-$)
  • CDF chair regrets undermining NICE (PMLive)

India

  • Assistant Commissioner of Indian FDA Caught Taking Bribes (Business Standard) (IndiaTimes)
  • Inside India: The Deadly Effects of Red Tape on Drug Approvals (WSJ)
  • DCGI writes to DoP to urgently address countrywide shortage of human albumin (PharmaBiz)
  • HS Kamble to take over as new Commissioner of Maharashtra FDA today (PharmaBiz)

China

Australia

  • Australia to Drop Proposed Biosimilar Naming Convention (PharmaLetter-$) (TGA)

Other International

Clinical Trials

  • Sharing Older Clinical Trial Data Should be Judicious: Sim Explains (Pharmalot)
  • Half of all trials remain unpublished (AllTrials)

General Regulatory And Interesting Articles

  • FDA Approves New Drug For Treating Pill Deficiencies (The Onion – SATIRE)
  • This Big Pharma Won't Invent Medicines. Investors Are Cheering. (Forbes)
  • Interview On Making The Batteryless Cardiac Pacemaker Powered By An Automatic Watch Movement (Forbes)
  • The Financial Consequences of a Bad Flu Shot (The Atlantic)

Regulatory Reconnaissance #476 – 21 January 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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