Regulatory Focus™ > News Articles > Regulatory Recon: Another Indian Drugmaker on FDA's Compliance Radar (23 February 2015)

Regulatory Recon: Another Indian Drugmaker on FDA's Compliance Radar (23 February 2015)

Posted 23 February 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Another Indian Drugmaker on FDA's Compliance Radar (23 February 2015)

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

In Focus: US

  • India's Lupin says FDA raises concerns over plant at Pithampur (Reuters)
  • Label Change Proposal From GPhA, PhRMA Makes FDA Responsible For Timing (Pink Sheet-$)
  • How Orphan Drugs Came to Be Called “Orphan” (FDA Law Blog)
  • Overkilling Withdrawn Drugs: FDA Gives Thorough Reassessment For Do-Not-Compound List (RPM Report-$)
  • Compound Pharmacies Complain FDA is Compounding Their Problems (Pharmalot)
  • FDA to exempt carrier tests from premarket review (BioCentury) (Forbes) (HealthDay)
  • FDA Approves Medtronic's Varicose Vein Adhesive (MedPage Today) (Reuters) (WSJ-$) (FDA) (FDA)
  • U.S. health officials push for stricter medical device 'superbug' defense (Reuters)

In Focus: International

  • EMA introduces weekly start dates for the assessment of type II variations from March 2015 (EMA)
  • Committee chairs’ handwritten signatures no longer included in opinion documents from March 2015 (EMA)
  • EMA calls for industry involmnent in applying new ISO standards to drugs (In-Pharma) (Pharmafile) (EMA)
  • German thalidomide survivors continue fight for compensation (Guardian)
  • WHO calls for worldwide use of "smart" syringes (WHO) (BBC)
  • The telltale heart device: Pacemaker used to clear innocent man of murder charge (Mass Device)

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US: Pharmaceuticals and Biotechnology

  • Label Change Proposal From GPhA, PhRMA Makes FDA Responsible For Timing (Pink Sheet-$)
  • How Orphan Drugs Came to Be Called “Orphan” (FDA Law Blog)
  • India's Lupin says FDA raises concerns over plant at Pithampur (Reuters)
  • Overkilling Withdrawn Drugs: FDA Gives Thorough Reassessment For Do-Not-Compound List (RPM Report-$)
  • Compound Pharmacies Complain FDA is Compounding Their Problems (Pharmalot)
  • US FDA to involve Indian regulators for inspections to create awareness about its inspection activities in India (PharmaBiz)
  • Combo Products Guidance Could Help Point Novel OTC Switches In Right Direction (Tan Sheet-$)
  • Avedro’s Eye Drug-Device Combo Haunted By Past Sponsor’s Decisions (Pink Sheet-$) (Tarius)
  • FDA Sentinel Transition Will Involve Expanding Rx Safety Data Sources (Pink Sheet-$)
  • When Will The DSCSA Ever Require Investments In Aggregation? (RxTrace)
  • J&J Hid Risperdal Risks of Boy Breast Development, Jury Told (Bloomberg)
  • Detecting Unexpected Adverse Events: Gardasil Study Aims For Holy Grail (Pink Sheet-$)
  • Women Fooled By Untested Hormones From Compounding Pharmacies (Forbes)
  • Idaho: Biosimilar Notification Bill Introduced (Scout)
  • New Adverse Event Comparison Tool Launched by Company (AdverseEvents)
  • FTC swats anti-mosquito band maker's marketing claims (Reuters)
  • NAD recommends Boehringer Ingelheim discontinue 'maximum strength' claim for DulcoGas product (MNT)

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

  • Regeneron, Sanofi outline promising PhIIb data for top blockbuster pick dupilumab (Fierce)
  • FDA Accepts BLA Filing For Synageva's Kanuma (Sebelipase Alfa); Grants Priority Review And Assigns PDUFA Date (Press)
  • Taiho Oncology, Inc. Announces TAS-102 New Drug Application for Refractory Metastatic Colorectal Cancer Accepted for Review by FDA (Press)
  • Eli Lily's Baricitinib Superior to Placebo in Reducing Rheumatoid Arthritis Disease Activity in Second Phase 3 Study (Press)
  • Pfizer seeks Rapamune approval for rare lung disease (PharmaTimes) (Press)
  • Novo's oral version of semaglutide impresses in Phase II (PharmaTimes)
  • Endo Pharmaceuticals and BioDelivery Sciences Announce Acceptance of NDA for BELBUCA (buprenorphine HCl) Buccal Film for the Management of Chronic Pain (Press)
  • Celldex's Rindopepimut (Rintega(R)) Receives FDA Breakthrough Therapy Designation for the Treatment of Adult Patients with EGFRvIII-positive Glioblastoma (Press)

US: Pharmaceuticals and Biotechnology: General

  • Dem pushes Holder to reclassify marijuana (The Hill) (Reuters)
  • The Need For Publicly Funded Trials To Get Unbiased Comparative Effectiveness Data (HealthAffairs)
  • FedEx Scores Partial Wins In DEA Subpoena Fight (Law 360-$)

US: Medical Devices

  • FDA to exempt carrier tests from premarket review (BioCentury) (Forbes) (HealthDay)
  • FDA Approves Medtronic's Varicose Vein Adhesive (MedPage Today) (Reuters) (WSJ-$) (FDA) (FDA)
  • U.S. health officials push for stricter medical device 'superbug' defense (Reuters)
  • As Snow Falls, We See a Flurry of Developments Related to FDA Efforts to Actively Regulate LDTs (FDA Law Blog)
  • FDA Removes Unregistered Medical Device Establishments from Database (Registrar Corp)
  • AMP Recommends FDA Focus on Evaluating and Ensuring Consistent Performance of Next Generation Sequencing Diagnostic Tests (Press)
  • US regulators try to tame 'wild west' of DNA testing (Nature)
  • Medtronic prepares to head back to FDA with deep brain stimulation for epilepsy (Fierce) (Mass Device)
  • The future of medical device safety and innovation (Brookings)

US: Dietary Supplements

  • Bayer Probiotic Claim Defense Argues FTC Wants Substantiation Standard That ‘Did Not Exist’ (Tan Sheet-$)
  • Synutra CEO: ‘We expect quicker adoption of validated chondroitin testing methods in light of NY AG actions’ (NI-USA)

US: Assorted And Government

  • Enforcement Report - Week of February 18, 2015 (FDA)

Upcoming Meetings

Ebola Outbreak

  • New funding announced for US Ebola preparedness (The Hill)

Europe

  • EMA introduces weekly start dates for the assessment of type II variations from March 2015 (EMA)
  • Committee chairs’ handwritten signatures no longer included in opinion documents from March 2015 (EMA)
  • EMA calls for industry involmnent in applying new ISO standards to drugs (In-Pharma) (Pharmafile) (EMA)
  • German thalidomide survivors continue fight for compensation (Guardian)
  • EU Doctors Decry Lack of Pediatric Drug Testing (GulfNews)
  • Celltrion Remicade biosimilar gathers momentum in EU (PharmaTimes)
  • EC Grants Orphan Designation to 15 Drugs (European Commission)
  • Council of Europe publishes new guide on Umbilical Cord Blood Banking for soon-to-be parents (EDQM)
  • Intas Pharma launches its first biosimilar product Accofil in Europe (IndiaTimes)

India

  • Insight On India – Highlights From The Week Of Feb 15-21, 2015 (Two-Four Insight)

Australia

  • Medicines forecast to cost taxpayers millions more in secret TPP trade deal (Guardian)

Other International

  • WHO calls for worldwide use of "smart" syringes (WHO) (BBC)
  • Nigeria: NAFDAC Destroys N500 Million Fake Drugs in Anambra (AllAfrica)

General Regulatory And Interesting Articles

  • The telltale heart device: Pacemaker used to clear innocent man of murder charge (Mass Device)
  • Pills that Help Addicts Quit Have a Catch (SciAm)
  • Pancreas-In-A-Capsule Enters Clinical Trials (MedicalDeviceOnline)

Regulatory Reconnaissance #499 – 23 February 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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