Regulatory Focus™ > News Articles > Regulatory Recon: FDA Tests Show 1.1% of Drugs Don't Meet Quality Standards (3 November 2014)

Regulatory Recon: FDA Tests Show 1.1% of Drugs Don't Meet Quality Standards (3 November 2014)

Posted 03 November 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Tests Show 1.1% of Drugs Don't Meet Quality Standards (3 November 2014)

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

In Focus: US

  • Annual Testing Of Drugs for Quality By The FDA: 1.1% of Tested Drugs Don't Meet Quality Standards (Two-Four Insight)
  • Generic Manufacturing Reviews Getting Speedier Communication Program (Pink Sheet-$)
  • Abuse-Deterrent Opioids: FDA Regulatory Options Aired At Meeting (Pink Sheet-$)
  • FDA vs. EU Inspections: Similarities & Differences (GxP Lifeline)
  • Paving the critical path of drug development: the CDER perspective (Nature)
  • Small Device Maker Fights FDA on ‘Grandfather’ Claim (MDDI)
  • Don’t Be Haunted By Making Poor Post-Market Surveillance Choices (Silver Sheet-$)
  • Boston Scientific faces first federal transvaginal mesh trials (Reuters)
  • NPA to FDA: Consumer Advisory on Supplements, Drugs Is ‘Misleading’ (NPI)

In Focus: International

  • EMA starts review of Biogen Idec's haemophilia A therapy (PMLive) (Press)
  • India Wants to Cut Down on API Imports (LiveMint)
  • Recent Regulatory Developments in India (Two-Four Insight)
  • Australia thrashes out patient access deals for Soliris/Kalydeco (SCRIP-$)

US: Pharmaceuticals and Biotechnology

  • Generic Manufacturing Reviews Getting Speedier Communication Program (Pink Sheet-$)
  • Sarepta silent on FDA's riposte (BioCentury)
  • Abuse-Deterrent Opioids: FDA Regulatory Options Aired At Meeting (Pink Sheet-$)
  • Annual Testing Of Drugs For Quality By The FDA (Two-Four Insight)
  • Pediatric summit explores growing issue of risk vs. benefits of rare disease drugs (BioFlash)
  • FDA vs. EU Inspections: Similarities & Differences (GxP Lifeline)
  • Edoxaban Review Spurs FDA Call For Changes In Anticoagulant Trials (Pink Sheet-$)
  • Sanofi's Duty To Detail FDA Concerns Key To Lemtrada Cases (Law 360-$)
  • FDA Asks Generics Makers to Help Fill in Gaps in Bioequivalence Testing Guidance (FDA News-$)
  • US Capitol Capsule: Power to the people: Patients' influence over FDA (SCRIP-$)
  • FDA Export Bans Plunge Wockhardt Profits (Reuters)
  • Who Is A DSCSA Repackager? (RxTrace)
  • New labeling sought for longtime cancer drug tamoxifen (USA Today)
  • Lannett Announces Positive FDA Inspection Results (Press)
  • Recall for Buffered Formalin Due to Incorrect Concentration (FDA)

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

  • FDA Medicare study in 134,000 atrial fibrillation patients confirms positive safety profile and effectiveness of BI's Pradaxa in general practice (Press)
  • Veloxis respectfully begs to differ with FDA (BioCentury)
  • Unusual Clinical Trial for Nanoparticles Clears Safety Testing (DD&D)
  • Nymox blasted as lead drug flops in twin PhIII enlarged prostate studies (Fierce) (PharmaTimes)
  • FDA Grants Orphan Drug Designation To Basilea's Isavuconazole (RTT) (Press)
  • Promedior Receives Fast Track Designation for PRM-151 for the Treatment of Myelofibrosis (Press)
  • Geron shares rocket up after FDA takes the cuffs off its lead drug (Fierce)
  • Dr Reddy's Laboratories may file new drug applications with FDA within year (India Times)

US: Pharmaceuticals and Biotechnology: General

  • Viagra's Come-Hither Ad Campaign (Bloomberg)
  • GSK, Sanofi see setbacks in flu vaccine production for US market (In-Pharma)

US: Medical Devices

  • Small Device Maker Fights FDA on ‘Grandfather’ Claim (MDDI)
  • How to Design for Compliance: Tips for Getting (and Keeping) Your New Product on the Market (GxP Lifeline)
  • Don’t Be Haunted By Making Poor Post-Market Surveillance Choices (Silver Sheet-$)
  • Boston Scientific faces first federal transvaginal mesh trials (Reuters)
  • Syneron Medical Says FDA Clears New PicoWay Picosecond Device (RTT)
  • HyperQ High-Res ECG Technology FDA Cleared to Diagnose Heart Attacks (MedGadget)
  • Class 1 Device Recall Baxter 2B8011 Empty INTRA VIA Container with PVC Ports (FDA)
  • Paragonix Technologies Inc., Announces Filing of two 510(k) Pre-Market Notifications with the Food and Drug Administration (Press)

US: Dietary Supplements

  • NPA to FDA: Consumer Advisory on Supplements, Drugs Is ‘Misleading’ (NPI)
  • 7th Circ. Casts A Wary Eye On Supplement Labeling Deal (Law 360-$)

US: Assorted And Government

  • New FDA Guidances for October 2014 (CATO)
  • Looking Ahead to the 21st Century Cures Act in the Next Congress (BioCenturyTV)

Upcoming Meetings

Ebola Outbreak

  • WHO toughens standards for Ebola protective gear (The Hill) (WHO)
  • Using the fear of Ebola to promote the placebo legislation that is “right to try” (Science-Based Medicine)
  • Ebola update: WHO works with vaccine makers on production bottlenecks (BioPharma Reporter)
  • Patents Not an Issue in the Fight Against Ebola (BIO)

Europe

  • EMA starts review of Biogen Idec's haemophilia A therapy (PMLive) (Press)
  • Netherlands Kiadis gets EMA orphan drug status for ATIR to treat acute myeloid leukemia (Press)

India

  • Indian panel outlines principles for review of essential drugs list (SCRIP-$)
  • Insight On India – Highlights For The Week Of Oct 26-Nov 1, 2014 (Two-Four Insight)
  • India Wants to Cut Down on API Imports (LiveMint)
  • Health Ministry to grant clinical trial waiver for cancer drugs Aflibercept, Trastuzumab emtansine (PharmaBiz)

Australia

  • Australia thrashes out patient access deals for Soliris/Kalydeco (SCRIP-$)
  • Australia's Pharmceuticals Industry Council to cease operation (PharmaLetter-$)

Clinical Trials

  • Paving the critical path of drug development: the CDER perspective (Nature)
  • The Clinical Trials Transformation Initiative: innovation through collaboration (Nature)
  • Reporting of primary analyses and multiplicity adjustment in recent analgesic clinical trials: ACTTION systematic review and recommendations. (PubMed)
  • Pregnant women must be studied too (The Conversation)

General Regulatory And Interesting Articles

  • Of human-on-a-chip and humans: Considerations for creating and using microphysiological systems (SAGE)
  • Blood pressure devices giving inaccurate readings, study finds (PharmJournal)
  • Scientists seek to make remote-controlled drug delivery device that works in space (BioPharma Dive)
  • Hopes for single blood test to detect many cancer types (PharmaTimes)

Regulatory Reconnaissance #432 – 3 November 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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