Regulatory Focus™ > News Articles > Regulatory Recon: Indian Pharma Plans Big Investment in Regulatory Affairs (12 August 2014)

Regulatory Recon: Indian Pharma Plans Big Investment in Regulatory Affairs (12 August 2014)

Posted 12 August 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Indian Pharma Plans Big Investment in Regulatory Affairs (12 August 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

  • Mixed Results in FDA's Annual Antibiotic Resistance Survey (Farm Futures) (FDA)
  • FDA reports serious violations at IPCA's Ratlam facility (Business Standard) (Fierce) (CNBC)
  • Should FDA Rethink CV Safety Requirements? (Pink Sheet-$) (SCRIP-$)
  • AIDS Activist Takes Up A New Fight: Defending FDA (AP)
  • Wockhardt Q1 net profit falls 94% on FDA plant bans (Reuters)
  • FDA approves first DNA-based test for colon cancer (Modern Healthcare) (Press) (FDA) (Bloomberg) (Herald Sun) (WSJ-$) (Bloomberg)
  • Panel discusses legal, ethical concerns of 3D printing (ABA)
  • Complaint File Management for Medical Device Manufacturers (MDDI)
  • Drawing the Line between Liquid Dietary Supplements and Beverages: What Every Dietary Supplement Manufacturer Needs to Know (DRI)

In Focus: International

  • WHO backs use of experimental Ebola drugs in West Africa outbreak (Reuters) (WHO) (AP) (Bloomberg) (SCRIP-$)
  • White House, FDA Approve Export of Experimental Ebola Drug to Liberia (CNN) (PharmaPhorum) (Reuters) (NBC) (Reuters)
  • Ebola test drug’s supply ‘exhausted’ after shipments to Africa, U.S. company says (WaPo) (WSJ-$) (Bloomberg)
  • EC approves Eylea for DME (BioCentury) (Press)
  • India's Pharmaceutical Industry Plans Major Investment in Developing Regulatory Professionals (PharmaBiz)
  • Lawsuit Alleges DCGI Approved Cancer Vaccines Improperly (India Times)
  • Health Canada approves plan to fix flu vaccine plant problems (CTV)

US: Pharmaceuticals and Biotechnology

  • Mixed Results in FDA's Annual Antibiotic Resistance Survey (Farm Futures) (FDA)
  • FDA reports serious violations at IPCA's Ratlam facility (Business Standard) (Fierce) (CNBC)
  • Should FDA Rethink CV Safety Requirements? (Pink Sheet-$) (SCRIP-$)
  • AIDS Activist Takes Up A New Fight: Defending FDA (AP)
  • Wockhardt Q1 net profit falls 94% on FDA plant bans (Reuters)
  • Status of Spray Sunscreens Still Uncertain (MedPage Today)
  • Dancing with the Deval: Allowing states to circumvent FDA drug approvals would set a dangerous precedent (PMLive)
  • New Concerns About an Old Heart Drug, Digoxin (NYTimes) (Forbes)
  • ANDA Stability Requirements To Be Broadly Grandfathered, FDA Says (PharmAsia-$)
  • FDA Declines To Issue Rulemaking For Section 505(B)(2) NDA Therapeutic Equivalence Ratings (Duane Morris)
  • Tweet, Tweet, Tweet: Pharma Finding Its Niche on Twitter? (Pink Sheet-$)
  • Vimizim Voucher A Result Of BioMarin’s Late Request, FDA Flexibility (Pink Sheet-$)
  • Pew and Partners Comment on FDA’s Suspect Product Guidance (Pew)
  • Faster FDA Approvals Have Not Caused More Drug Safety Problems (Forbes)
  • CMO issues persist as Cubist announces third recall for potential glass in antibiotic (In-Pharma)
  • Sen. Schumer to address alleged potential Lyme disease drug shortage (Record Online)
  • Mylan unveils generic version of Genentech’s Xeloda for breast and colon cancers (MedCity News)
  • Non-Personnel Costs Dominate Generic Drug Review (Pink Sheet-$)
  • How FDA Will Take Away A ‘Breakthrough’ Designation (Pink Sheet-$)
  • Waiting for the FDA to Get It Right on Triclosan (NRDC)
  • FDA’s Antiparasitic Resistance Management Strategy - A Webinar (FDA)
  • Fresenius Kabi Introduces New Version of Propofol (Press)

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

  • FDA Expecting 10 Biosimilar Applications Submitted By End Of FY 2015 (Pink Sheet-$)
  • Novartis will file heart failure drug before year-end (Pharmafile)
  • Positive new Ph III data with Novo Nordisk’s Xultophy (Pharma Letter-$)
  • BioDelivery Sciences Announces BEMA Buprenorphine NDA Submission on Track following Pre-NDA Meeting with FDA (Press)
  • Insys Submits NDA For New Oral Formulation Of Dronabinol (RTT)
  • Intercept Releases Positive Data on Liver Drug (WSJ-$) (SCRIP-$) (Reuters)
  • Rayaldee Phase 3 Trial Meets Primary Endpoints (Pipeline Review)
  • Mirati Lymphoma Drug Designated Orphan Drug (Press)
  • FDA Grants Orphan Drug Designation for OncoSynergy's Investigational Monoclonal Antibody OS2966 in the Treatment of Glioblastoma (Press)
  • Janssen plans a 4th Phase 3 trial for breakthrough multiple myeloma therapy (Medcity News)

US: Pharmaceuticals and Biotechnology: General

  • Do You Find Prescription Labels Hard to Read? You Are Not Alone (USP)
  • Institutional investors decry US battle over biosimilars (BioPharma Reporter) (Pharmalot)
  • Drug compounding law presents challenges, opportunities for physicians (Family Practice News)
  • The Case Against RFID In Pharma (RxTrace)
  • A Cancer Innovation Crisis? Misplaced Incentives Promote Marginal Benefits, JAMA Study Says (Pink Sheet-$)
  • What you need to know about prescription traceability (Packaging Digest)

US: Medical Devices

  • FDA approves first DNA-based test for colon cancer (Modern Healthcare) (Press) (FDA) (Bloomberg) (Herald Sun) (WSJ-$) (Bloomberg)
  • Panel discusses legal, ethical concerns of 3D printing (ABA)
  • Complaint File Management for Medical Device Manufacturers (MDDI)
  • Lab Groups’ LDT Comments Will Highlight Barriers To Test Accessibility (Gray Sheet-$)
  • FDA has set the playing field for regulatory, legislative endgame on LDTs (BioCentury-$)
  • Apple prepares Healthkit rollout amid tangled regulatory web (Reuters)
  • Former MelaFind CEO's Take on FDA Approval (WSJ-$)
  • How to Conduct Design Research for Home Healthcare Devices (MDDI)
  • Cutera Receives FDA 510(k) Clearance for enlighten(Press)
  • Schumer: Fitness data collection is ‘privacy nightmare’ (The Hill)
  • BioTime Receives FDA Premarket Notification Clearance for Premvia 510(k) (Press)

US: Dietary Supplements

  • FDA Chemical Hazard Early-Detection Program Seeks ‘Potential’ Risk Data (Tan Sheet-$)
  • Drawing the Line between Liquid Dietary Supplements and Beverages: What Every Dietary Supplement Manufacturer Needs to Know (DRI)
  • FDA To Allow Vitamin D3 In More Meal Replacement Shakes  (Law 360-$) (FDA) (Tan Sheet-$)
  • Firm Halting Sales of Dietary Supplement Anatabloc (AP)

Ebola Outbreak

  • WHO backs use of experimental Ebola drugs in West Africa outbreak (Reuters) (WHO) (AP) (Bloomberg) (SCRIP-$)
  • White House, FDA Approve Export of Experimental Ebola Drug to Liberia (CNN) (PharmaPhorum) (Reuters) (NBC) (Reuters)
  • Ebola test drug’s supply ‘exhausted’ after shipments to Africa, U.S. company says (WaPo) (WSJ-$) (Bloomberg)
  • Eradicating Ebola: In U.S. Biomedical Research, We Trust (NIH)
  • First US Ebola Outbreak Stopped 25 Years Ago (AP)
  • If Ebola Arrives In The U.S., Stopping It May Rely On Controversial Tools (Forbes)
  • U.S. Plans To Use Toyama’s Favipiravir In Ebola Fight (PharmAsia-$)
  • Should experimental drugs be used in the Ebola outbreak? (Nature)
  • S. Korea May Allow Fujifilm To Market Flu Drug As Ebola Treatment (PharmAsia-$)
  • Spanish priest with Ebola dies in Madrid hospital (Reuters)

Europe

India

  • India's Pharmaceutical Industry Plans Major Investment in Developing Regulatory Professionals (PharmaBiz)
  • Lawsuit Alleges DCGI Approved Cancer Vaccines Improperly (India Times)
  • MCI asked to look into bribery charges against doctors (India Times)
  • Industry fears stringent regulation on FDCs may impact FDI in pharma sector (PharmaBiz)
  • Govt should stall approval of ‘sound-alike’ drugs to prevent dispensing errors & adverse reactions: Dr BR Jagashetty (PharmaBiz)

Canada

  • Health Canada approves plan to fix flu vaccine plant problems (CTV) (
  • Kythera Submits Chin Fat Reduction Drug in Canada (Press)

Other International

Clinical Trials

  • Drug Supply Shortages in Clinical Trials: Part 2 – How Shortages Impact Studies (BioClinica)

General Regulatory And Interesting Articles

  • Incretin-based anti-diabetic therapies: a pharmacovigilance perspect (PharmaPhorum)
  • Newborns Commonly Are Exposed in Womb to Germ-Killing, Endocrine-Disrupting Chemicals (Scientific American) (CBS)

Regulatory Reconnaissance #377 – 12 August 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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