Regulatory Focus™ > News Articles > Regulatory Reconnaissance: FDA to Quietly Begin Major Generic Drug Testing Effort (24 February 2014)

Regulatory Reconnaissance: FDA to Quietly Begin Major Generic Drug Testing Effort (24 February 2014)

Posted 24 February 2014 | By Alexander Gaffney, RAC 

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In Focus: US

  • Generic-Drug Testing Goes Widespread in FDA Effort (Bloomberg)
  • Vertex wins broader use of Kalydeco in CF (SCRIP-$) (Pharma Letter-$) (BioFlash) (BioCentury) (Press)
  • FDA chief: We are not targeting Indian companies (SCRIP-$) (Business Standard)  (IBN)
  • FDA Denies 3 Petitions Seeking NCE Exclusivity for Combo Drugs, But Proposes to Reinterpret the Law for New NDAs (FDA Law Blog)
  • Purdue Pharma Petitions FDA to Apply ER/LA Requirements to IR Opioid Analgesics (FDA Law Blog)
  • FDA Panel Gives OSA 'Pacing' Thumbs Up (MedPage Today)
  • Study of Three Popular DTC Genomic Testing Services Finds "Marked Differences" (ClinChem)
  • John Dingell, longest serving U.S. representative, to retire (Detroit Free Press)

In Focus: International

  • Europe's health care industry calls for balanced and transparent funding of the EU pharmacovigilance system (Pharma Letter-$) (Pharma Times) (PharmExec)
  • The EU's Qualified Person for device regulatory compliance: a tall order to meet? (Clinica-$)
  • Four companies request CHMP second opinion (SCRIP-$)
  • EMA Releases Guidelines on Labeling of Three Excipients: (Ethanol) (Benzyl alcohol) (Benzoic acid and Benzoates)
  • J&J's Cordis won a CE mark for its renal denervation device (Fierce) (Press)
  • Ranbaxy Axes Staff At Toansa API Site As Internal Probe Gains Speed (Pink Sheet-$)

US: Pharmaceuticals/Biotechnology

  • Generic-Drug Testing Goes Widespread in U.S. FDA Effort (Bloomberg)
  • Vertex wins broader use of Kalydeco in CF (SCRIP-$) (Pharma Letter-$) (BioFlash) (BioCentury) (Press)
  • FDA chief: We are not targeting Indian companies (SCRIP-$) (Business Standard)  (IBN)
  • FDA adding more inspectors in India to monitor pharmaceutical industry (AP)
  • FDA Denies 3 Petitions Seeking NCE Exclusivity for Combo Drugs, But Proposes to Reinterpret the Law for New NDAs (FDA Law Blog)
  • Purdue Pharma Petitions FDA to Apply ER/LA Requirements to IR Opioid Analgesics (FDA Law Blog)
  • EHR notes, data analytics help track off-label drug use (EHR Intelligence)
  • Amarin Loses Bid for Vascepa 5-Year Market Exclusivity (The Street)
  • Visiting India: The Importance of Biomedical Research and Quality (FDA)
  • FDA Questions Reformulated Primatene Asthma Spray Reliability (Tan Sheet-$)
  • Endo to Pay $192 Million Over Off-Label Marketing Charges (DOJ)
  • FDA Needs Formal Mechanism To Integrate Patient Input, Groups Say (Pink Sheet-$)
  • Systematizing Patient Views Unlikely, FDA's Temple Says (Pink Sheet-$)
  • Vertex Pharma Swaps Endpoints in Key Cystic Fibrosis Studies (The Street)
  • A Legal Guide To Medication Guides (D&D Law)
  • BioMarin Tests FDASIA's Pediatric Voucher Waters With Vimizim Approval (Pink Sheet-$)
  • Decoding The FDA's DSCSA Timeline (RxTrace)
  • Confidence, Trust, and 21st Century Pharmacovigilance (DrugWonks)

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

  • Salix and Pharming Announce Extension of PDUFA Action Date for RUCONEST (Press)
  • Pfizer Announces Positive Top-Line Results Of Landmark Community-Acquired Pneumonia Immunization Trial In Adults (CAPiTA) Evaluating Efficacy Of Prevenar 13 (Press)
  • Isis hits another new high on SMA data (SCRIP-$)
  • Bristol-Myers Squibb Receives FDA Breakthrough Therapy Designation for All-Oral Daclatasvir Dual Investigational Regimen for Chronic Hepatitis C (Press)
  • Auxilium Pharmaceuticals, Inc. Announces The FDA Acceptance Of Application Requesting Approval Of XIAFLEX For The Concurrent Treatment Of Multiple Palpable Cords (Market Watch)

US: Pharmaceuticals and Biotechnology: General

  • As health care costs level, pharmaceuticals take a wild jump (MedCity News)
  • Novartis provides second US university with Bexsero® to help protect students and staff against potentially deadly meningitis B disease (Press)

US: Medical Devices

  • FDA Panel Gives OSA 'Pacing' Thumbs Up (MedPage Today)
  • Study of Three Popular DTC Genomic Testing Services Finds "Marked Differences" (ClinChem)
  • Paragonix Technologies Inc., Announces Clearance of a Second 510(k) Premarket Notification by FDA for the Paragonix Sherpa Cardiac Transport System (Press)

US: Dietary Supplements

  • New Law Would Reduce Steroids Marketed as Supplements (NPI)

US: Assorted And Government

  • John Dingell, longest serving U.S. representative, to retire (Detroit Free Press)
  • SCRIP's US Capitol Capsule Roundup (SCRIP-$)
  • PWC's Weekly Regulatory Wrapup (PWC) 

Upcoming Meetings And Events

  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

  • Europe's health care industry calls for balanced and transparent funding of the EU pharmacovigilance system (Pharma Letter-$) (Pharma Times) (PharmExec)
  • CHMP Clears Pierre Fabre's Hemangiol For Children, Under Rarely Used Pediatric Pathway (Pink Sheet-$)
  • The EU's Qualified Person for device regulatory compliance: a tall order to meet? (Clinica-$)
  • Four companies request CHMP second opinion (SCRIP-$)
  • EMA Releases Guidelines on Labeling of Three Excipients: (Ethanol) (Benzyl alcohol) (Benzoic acid and Benzoates)
  • J&J's Cordis won a CE mark for its renal denervation device (Fierce) (Press)
  • EMA predicts 'no ADC influx' following Roche's Kadcyla launch (BioPharma Reporter)
  • Impact report gives insight into EU drug safety features (Securing Industry)
  • MSF warns of impact of proposed EU trade mark infringement measures (Pharma Letter-$)
  • European Commission Grants Orphan Drug Designation to Soliris (Eculizumab) for Prevention of Delayed Graft Function (DGF) after Solid Organ Transplantation (Press)

India

  • Ranbaxy Axes Staff At Toansa API Site As Internal Probe Gains Speed (Pink Sheet-$)
  • India Said To Deny Visas To U.S. Trade Panel To Probe IP Rights Issues (PharmAsia-$)
  • Health ministry issues guidance document for approvals of stem cells, cell based products (PharmaBiz)

Regulatory Reconnaissance #262 - 24 February 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.


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