Regulatory Focus™ > News Articles > Regulatory Recon: FDA's India Office Loses Leader (18 July 2014)

Regulatory Recon: FDA's India Office Loses Leader (18 July 2014)

Posted 18 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: FDA's India Office Loses Leader (18 July 2014)

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In Focus: US

In Focus: International

  • EMA Responds Robustly to Conflict-of-Interest Claims (PharmExec)
  • Could U.S./EU Trade Pact Let Pharma Fight EU Drug Cost Controls In Court? (Pink Sheet-$)
  • French HM backs low-key choice to head medicines agency (SCRIP-$)
  • China Allows Open Trial for Two Glaxo Investigators (WSJ-$)

US: Pharmaceuticals and Biotechnology

  • FDA, DOJ Indict FedEx Over Role in Shipping Counterfeit Drugs (FDA) (DOJ) (WSJ-$) (Law 360-$)
  • FDA's India Office Struggles to Take Shape as Leader Leaves (Bloomberg)
  • FDA approves Ruconest from Pharming, Salix (BioCentury) (Fierce) (Pharma Times) (SCRIP-$) (FDA) (MedPage Today)
  • FDA committee to discuss adverse effects of testosterone products (Reuters)
  • Pending Recall for Hospira, Vial Crimps Loose or Missing (FDA)
  • New Citizen petition on Levaquin Seeks Labeling Changes (FDA)
  • Animal Drug Industry, Frustrated With FDA, Raises Alarm On Compounding (IHP-$)
  • Important Role of Translational Science in Rare Disease Innovation, Discovery, and Drug Development (PubMed)
  • Group Urges FDA to Adopt an EU-Like Approach on Biosimilar Naming (Press)
  • Bone Safety Studies for Diabetes Trials: A Q&A (BioClinica)
  • Illinois Man Sentenced for Smuggling Counterfeit Goods and Drugs into the U.S. (DOJ)

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

  • InterMune's IPF pirfenidone wins US 'Breakthrough' status (Pharma Times) (Fierce)
  • GSK melanoma drugs beat rival in new study (Pharmafile) (BioCentury) (GSK)
  • Amgen announces positive Phase III results for AMG 416 in kidney disease (Pharma Letter-$) (Fierce) (SCRIP-$)
  • Bayer Phase III Trial of Aflibercept Shows Improvement in Diabetic Macular Edema (Press)
  • Flu Drug Fighting Resistant Strains to Seek U.S. Approval (Bloomberg)

US: Pharmaceuticals and Biotechnology: General

  • NIH system to monitor emerging drug trends (NIH)
  • Oregon to Pharma: Let’s Make a Deal on Hepatitis C Drugs (Pharmalot)
  • FTC Looks To Join Lamictal Pay-For-Delay Oral Args (Law 360-$)

US: Medical Devices

  • Academic labs argue against FDA guidance on LDTs (BioCentury) (Gray Sheet-$) (NECIR)
  • FDA win lets SynCardia artificial heart patients out of the hospital (Mass Device)
  • FDA Develops Case Studies, Curriculum for Medical Devices (FDA)
  • FDA dings Spinal Elements for design changes, unreviewed claims (Mass Device)
  • Blue Belt Technologies Receives 510(k) Clearance for Patellofemoral Joint Replacement Application (Press)
  • Synergy Biomedical Announces Expanded FDA Clearance of BIOSPHERE PUTTY for Spine Indications (Press)

US: Dietary Supplements

  • Understanding the Safety and Regulation of Dietary Supplements (Diane Rehm Show)
  • Best Practices for Submitting Supplement AERs to FDA (Tan Sheet-$)

US: Assorted And Government

  • FDA Enforcement Report (FDA)
  • It's Here: First Local Chikungunya Cases in Florida (NBC) (CDC)

Europe

  • EMA Responds Robustly to Conflict-of-Interest Claims (PharmExec)
  • Could U.S./EU Trade Pact Let Pharma Fight EU Drug Cost Controls In Court? (Pink Sheet-$)
  • French HM backs low-key choice to head medicines agency (SCRIP-$)
  • Concept paper on transferring quality control methods validated in collaborative trials to a product/laboratory specific context (EMA)
  • More delays in EU for new medtech symbols standard as old standard reinstated (Clinica-$)
  • Basilea submits MAA for isavuconazole (BioCentury)
  • New EDQM Publication on Blood Supply Management (EDQM)
  • Threshold for statin use should be halved, says NICE (Pharma Times)
  • EU court says unfertilized ova not human embryos (BioCentury)

India

  • Pharmexcil, CDSCO to work with Vietnamese drug regulatory agency to address quality issues (PharmaBiz)

China

  • China Allows Open Trial for Two Glaxo Investigators (WSJ-$)

Other International

  • Medicines Patent Pool Speeds Availability of Generic HIV Drugs (DD&D)

General Regulatory And Interesting Articles

  • AIDS Experts Among Malaysia Airlines Victims (NBC) (MedPage Today) (Vox) (Reuters)
  • What do you do if your child has a condition that is new to science? (New Yorker)
  • More Flu Patients Get Antibiotics Than Antivirals, Study Reports (JAMA)
  • A Chip Offers a Faster and Cheaper Test for Type 1 Diabetes (MIT TR)
  • Tattoos may hold clues to medical conditions (Independent)

Regulatory Reconnaissance #360 – 18 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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