Regulatory Focus™ > News Articles > Regulatory Recon: Investigations Find Major Quality Problems at Indian Pharma Companies (3 December

Regulatory Recon: Investigations Find Major Quality Problems at Indian Pharma Companies (3 December 2014)

Posted 03 December 2014 | By Alexander Gaffney, RAC

Regulatory Recon: Investigations Find Major Quality Problems at Indian Pharma Companies (3 December 2014)

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

In Focus: US

  • Quality Out of Control: New Cracks in India's Drug Pipeline to U.S. (Bloomberg)
  • An Analysis of 510(k) Statistical Patterns (MDDI)
  • FDA panel wary of lifting ban on gay blood donors (AP) (Reuters) (NPR) (WSJ)
  • AstraZeneca Fights Billions in Possible Nexium Damages (Bloomberg)
  • FDA Quality Metrics Program Delayed, Extended to Biologics (FDAnews-$)
  • FDA warns AngioDynamics subsidiary Navilyst on hairs in PICC packaging (Mass Device)

In Focus: International

  • Novartis and Roche suffer setback in Italian collusion case (Reuters)
  • Germany bars antibiotic drug from Ranbaxy's central India plant (Reuters)
  • EU starts building trial data portal (SCRIP-$)
  • Where the Council, Commission and Parliament now stand on new EU device regs (Clinica-$)
  • India: Hundreds of drug units in state under grip of fear as FDA embarks on surprise inspection spree (PharmaBiz)
  • ICH Posts Update After Major Meeting (ICH)

US: Pharmaceuticals and Biotechnology

  • Quality Out of Control: New Cracks in India's Drug Pipeline to U.S. (Bloomberg)
  • FDA panel wary of lifting ban on gay blood donors (AP) (Reuters) (NPR) (WSJ)
  • AstraZeneca Fights Billions in Possible Nexium Damages (Bloomberg)
  • FDA Quality Metrics Program Delayed, Extended to Biologics (FDAnews-$)
  • FDA Starts Transition to Examining Quality Culture During Inspections (FDAnews-$)
  • Breakthrough Drug Initiative Success Creates Manufacturing Challenges (PharmExec)
  • HDMA Expresses Concerns About Industry Readiness for DSCSA (RxTrace)
  • Citizen Petition Seeks Pathway for Generic Suboxone (FDA)
  • Androgel Gets REMS Updates (FDA)
  • GFR Decline as an End Point in Trials of CKD: A Viewpoint From the FDA (PubMed)
  • FDA Perspective on Sofosbuvir Therapy for Patients With Chronic Hepatitis C Virus Genotype 1 Infection Who Did Not Respond to Treatment With Pegylated Interferon and Ribavirin (PubMed)
  • Regulation of biologic oncology products in the FDA׳s Center for Biologics Evaluation and Research (PubMed)

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

  • Puma Biotech Delays Breast Cancer Drug Filing to FDA (Bloomberg) (Fierce) (Press) (The Street)
  • CytRx Receives Written FDA Communication Regarding Partial Clinical Hold for Aldoxorubicin Clinical Trials (Press)
  • Sarepta Talks Directly To DMD Community About Eteplirsen Timelines (Pink Sheet-$) (SCRIP-$)
  • Dysport sBLA Under Review for Upper Limb Spasticity (MPR)

US: Pharmaceuticals and Biotechnology: General

  • Doctors Try to Influence a Medical Journal Poll on Testerone Treatments (Pharmalot)

US: Medical Devices

  • An Analysis of 510(k) Statistical Patterns (MDDI)
  • FDA warns AngioDynamics subsidiary Navilyst on hairs in PICC packaging (Mass Device)
  • Biofilms, medical devices, and antibiofilm technology: Key messages from a recent public workshop (PubMed)
  • Medtech Salary Survey 2014: Regulatory and Legal Affairs (MDDI)
  • Masimo wireless, wearable patient monitor cleared by FDA (Fierce)
  • FDA gives the green light to Stimwave's mini spinal cord stimulator (Mass Device) (Press)
  • Vascular Solutions Receives 510(k) Clearance For Turnpike Catheters (MedDeviceOnline)
  • GI View Ltd. Receives FDA 510(k) Clearance for the Aer-O-Scope™ Colonoscope System for Colorectal Cancer Screening (Press)

US: Assorted And Government

  • 7 Strategies for Avoiding cGMP FDA 483s (FDAzilla)
  • Chamber pledges fresh assault on regulation (The Hill)

Upcoming Meetings

Ebola Outbreak

  • FDA Supporting Scale-Up of Ebola Vaccine Production (White House)
  • GSK, NIH gear up for Ebola vaccine trial expansion after success in PhI (Fierce)
  • Ebola: A test of character (SCRIP-$)

Europe

  • Novartis and Roche suffer setback in Italian collusion case (Reuters)
  • Germany bars antibiotic drug from Ranbaxy's central India plant (Reuters)
  • EU starts building trial data portal (SCRIP-$)
  • Where the Council, Commission and Parliament now stand on new EU device regs (Clinica-$)
  • European Parliament hosts AMR crisis discussion (SCRIP-$)
  • Delegated Regulation on GMP for APIs published in the Official Journal of the EU (ECA)
  • European Medicines Agency Validates Marketing Authorization Application for Natpar® (parathyroid hormone (rDNA)) in Hypoparathyroidism (Press)

India

  • Hundreds of drug units in state under grip of fear as FDA embarks on surprise inspection spree (PharmaBiz)
  • Public interest groups urge DIPP's IPR Think Tank not to revisit India’s Patent Act (PharmaBiz)

Other International

  • ICH Posts Update After Major Meeting (ICH)
  • Asian Device Harmonization Group Admits Tanzania (PharmAsia-$)
  • Philipines FDA: Some batches of Hepa-A vaccine recalled (GMA Network)

Regulatory Reconnaissance #451 – 3 December 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