Regulatory Focus™ > News Articles > Regulatory Recon: Another Indian Pharma Company put on FDA Import Alert (22 September 2014)

Regulatory Recon: Another Indian Pharma Company put on FDA Import Alert (22 September 2014)

Posted 22 September 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Another Indian Pharma Company put on FDA Import Alert (22 September 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 here, or check out some of the mostnews-worthy sessions here.

In Focus: US

  • U.S. Congress urged to pass bill to speed development of antibiotics  (Reuters) (BioCentury) (Roll Call) (Pink Sheet-$) (Pew) (Woodcock) (E&C) (SCRIP-$)
  • FDA Affirms Office-Use Compounding Restrictions In Letter To Lawmakers (IHP-$)
  • FDA Changes Own Tweets To Match Industry Guidance (Pink Sheet-$)
  • Amgen Submits Biologics License Application for Investigational BiTE Immunotherapy Blinatumomab (Press)
  • Court Rejects FDA’s Interpretation of the Statute’s Device Definition as “Erroneous and Unreasonable” (Inside Medical Devices) (Fierce)
  • UDI architect shares compliance tips on eve of regulation's first deadline (Fierce)
  • Gynecologists Resist FDA Over Popular Surgical Tool (WSJ-$)

In Focus: International

  • India’s Micro Labs Gets FDA Import Alert For Goa Unit (PharmAsia-$) (FDA)
  • Gilead’s blood cancer pill Zydelig approved in Europe (Pharmafile) (PMLive) (BioCentury) (Fierce) (Pharma Times)
  • Regulatory experts push for pharma cos to strengthen data integrity in India (PharmaBiz)
  • India may relax rules on BA/BE studies in respect of drugs manufactured in India (PharmaBiz)
  • Pharma Serialization: Going Totally Global Soon (RxTrace)

US: Pharmaceuticals and Biotechnology

  • U.S. Congress urged to pass bill to speed development of antibiotics  (Reuters) (BioCentury) (Roll Call) (Pink Sheet-$) (Pew) (Woodcock) (E&C) (SCRIP-$)
  • FDA Affirms Office-Use Compounding Restrictions In Letter To Lawmakers (IHP-$)
  • FDA Changes Own Tweets To Match Industry Guidance (Pink Sheet-$)
  • Predicting the Near-Term Future of the Biotech Sector (BioCentury)
  • FCA Free Speech Defense Tested In DOJ-PhRMA Fight (Law 360-$)
  • The Next Estrogen Or An Off-Label Star: Can FDA Turn Back The Clock On Testosterone? (Pink Sheet-$)

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

  • Amgen Submits Biologics License Application for Investigational BiTE Immunotherapy Blinatumomab (Press)

US: Pharmaceuticals and Biotechnology: General

  • A Drug Mule for the Medicare Set: Canada, FDA and Drug Prices (NYTimes)
  • CDC: Plenty of flu vaccine expected; half quad (SCRIP-$)

US: Medical Devices

  • Bulletproofing The CAPA Process (Silver Sheet-$)
  • Court Rejects FDA’s Interpretation of the Statute’s Device Definition as “Erroneous and Unreasonable” (Inside Medical Devices) (Fierce)
  • UDI architect shares compliance tips on eve of regulation's first deadline (Fierce)
  • Gynecologists Resist FDA Over Popular Surgical Tool (WSJ-$)
  • Renal Denervation Produces Mixed Results In Small Sham-Controlled Trial (Gray Sheet-$)
  • Gore Receives FDA Approval for Endovascular Treatment of In-Stent Restenosis with the Gore Viabahn Endoprosthesis (Press)
  • Vertiflex’s Superion Interspinous Spacer Gets FDA Panel Date (Gray Sheet-$) (FDA)
  • Pew Comments to National Committee on Vital and Health Statistics on Unique Device Identifiers (Pew)
  • A Bill To … Direct The Development And Implementation Of A National Strategic Plan To Expedite Advancement Of Diagnostic Tools And The Transfer Of Such Tools To Patients (Bill)
  • Recall for CareFusion's EnVe and ReVel Ventilators (FDA)

US: Assorted And Government

Upcoming Meetings

Ebola Outbreak

  • Spain: Ebola Test Drug Out of Supply Worldwide (AP)

Europe

India

  • India’s Micro Labs Gets FDA Import Alert For Goa Unit (PharmAsia-$) (FDA)
  • Regulatory experts push for pharma cos to strengthen data integrity (PharmaBiz)
  • Health ministry may relax rules on BA/BE studies in respect of drugs manufactured in India (PharmaBiz)
  • Brazilian drug regulator to consider relaxing norms for Indian firms (Business Standard) (PharmAsia-$)

China

  • How Should Foreign Companies Interpret GSK's China Fines And Penalties? (Forbes)
  • After China, GlaxoSmithKline faces pressure for change (Reuters)

Japan

  • First Recommendation For HCV Drug Vaniprevir, In Japan (PharmAsia-$)
  • Bayer’s Eylea approved in Japan for myopic CNV (Pharma Letter-$) (Press)

Australia

  • TGA Warns About Serotonin-Blocking Medicine (TGA)

Other International

  • Pharma Serialization: Going Totally Global Soon (RxTrace)

General Regulatory And Interesting Articles

  • Pharma and Twitter: a happy marriage or time for a divorce? (Pharmafile)
  • Bacon as Nosebleed Treatment Nets Unusual Award (EMPR)

Regulatory Reconnaissance #404 – 22 September 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

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe