Regulatory Focus™ > News Articles > Regulatory Recon: Researchers Want FDA to Implement Clearer Drug Labels (28 July 2014)

Regulatory Recon: Researchers Want FDA to Implement Clearer Drug Labels (28 July 2014)

Posted 28 July 2014 | By Alexander Gaffney, RAC 

Regulatory Recon: Researchers Want FDA to Implement Clearer Drug Labels (28 July 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

  • How Well Does A Drug Work? Researchers Want Clearer Drug Labels (NPR)
  • Product Targeting for Paragraph IV Patent Challenges (Thomson Reuters)
  • FDA Black Box Warnings on NSAIDs had Significant Impact on Use (Wiley)
  • FDA Rejects AcelRx Painkiller Dispensing Device (SCRIP-$) (Press) (The Street) (Reuters)
  • Wockhardt Working to Get Out From Under FDA Import Ban (DNA India)
  • FBI Interviews Former, Current GSK Employees Over China Scandal (PharmAsia-$)
  • FDA Denies Citizen Petition’s Request to Ban Marketing of Non-Absorbable Surgical Mesh Products for Transvaginal Repair of Pelvic Organ Prolapse (Inside Medical Devices)
  • Trade Groups Say Caffeine Supplements Need More Marketing Caution, Not Regulation (Tan Sheet-$)

In Focus: International

US: Pharmaceuticals and Biotechnology

  • How Well Does A Drug Work? Researchers Want Clearer Drug Labels (NPR)
  • Product Targeting for Paragraph IV Patent Challenges (Thomson Reuters)
  • FDA Black Box Warnings on NSAIDs had Significant Impact on Use (Wiley)
  • FDA Rejects AcelRx Painkiller Dispensing Device (SCRIP-$) (Press) (The Street) (Reuters)
  • Timing of pre-dose baseline electrocardiograms in clinical trials: Increased sampling over a prolonged baseline period worsens variance of QTc (PubMed)
  • FDA Rejects Requests to Initiate Rulemaking for 505(b)(2) NDA Therapeutic Equivalence Rating Decisions (FDA Law Blog)
  • Wockhardt Working to Get Out From Under FDA Import Ban (DNA India)
  • Aqua Pharmaceuticals, LLC Announces the U.S. Food and Drug Administration (FDA) Approval of ACTICLATE (doxycycline hyclate USP) Tablets, 150 mg and 75 mg (Press)
  • Forest Labs' Hypertension Drug to go Before FDA AdComm (FDA)
  • Long-Shot Breast Cancer Drug Now Promises Fortune, but Not for Big Pharma (Bloomberg)
  • DSCSA: Special Privileges For The “Big-3″ Wholesale Distributors, Part 2 (RxTrace)
  • Antibiotics in animal feed and thin statutory interpretation: NRDC v. EPA (Harvard BOH)
  • Jakafi (ruxolitinib) Product Label Expanded to Include Overall Survival Data and Additional Safety and Dosing Information (Press)
  • Experts urge lifting ban on blood donations by gay men (CBS)

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

US: Pharmaceuticals and Biotechnology: General

  • FBI Interviews Former, Current GSK Employees Over China Scandal (PharmAsia-$)
  • Why Sovaldi took off: Previous treatments were terrible (WonkBlog)
  • Are Shippers Responsible for Legality of Goods They Transport? (WSJ-$)
  • Virus drugmaker fights pediatricians' new advice (AP)
  • J&J builds 9-month supply of Doxil with creative problem solving (Fierce)
  • Medicare Pressed to Bargain on Drug Costs (MedPage Today)
  • The business model for antibiotics is broken. Here are three alternatives you didn't know about (Vox)

US: Medical Devices

  • FDA Denies Citizen Petition’s Request to Ban Marketing of Non-Absorbable Surgical Mesh Products for Transvaginal Repair of Pelvic Organ Prolapse (Inside Medical Devices)
  • Upcoming study to dispute FDA's data on power morcellation risk (Fierce)
  • New Chlamydia and Gonorrhea Assays on the BD Viper LT System Receive FDA 510k Clearance (Press)
  • Class 1 Recall for GE Healthcare's Single-Width Airway Modules (FDA)
  • House questions FTC's health data, cybersecurity authority (Fierce)
  • AstraZeneca taps Roche, Qiagen for new blood-based cancer drug tests (Reuters)

US: Dietary Supplements

  • Trade Groups Say Caffeine Supplements Need More Marketing Caution, Not Regulation (Tan Sheet-$)
  • N.Y. Dietary Supplement Manufacturer Recalls Products Under Consent Decree (NPI)

Europe

  • War of letters over call to abolish EC scientific adviser role (Guardian)
  • Who influences NICE technology appraisals? (PharmaPhorum)
  • EU data plans 'could make cancer research impossible' (Pharma Times) (Pharmafile) (Burrill) (BioCentury)
  • NHS England's Sovaldi fund: opening the floodgates? (Pharmafile)
  • Allergan gets EU recommendation on new use of eye drug (Reuters)
  • Novartis says Alcon glaucoma treatment approved in EU (Reuters) (PharmaPhorum)
  • Pricing Of Zydelig And Imbruvica Will be Scrutinized After EMA Nod (Pink Sheet-$)
  • European regulators issue guidance on nanotechnology in medical devices (Mass Device)

India

  • Ranbaxy's Global Head of Quality out in Management Shakeup (India Times)
  • Pharma firms go to court against use of special power for price cuts (Business Standard)
  • India Price Cuts May Cause Broad Fallout, Industry Warns (Pink Sheet-$) (SCRIP-$)
  • Indian generic drugmakers set to score from MPP deals on HIV drugs (Pharma Letter-$)
  • Maha FDA Faces Shortage of Key Personnel (PharmaBiz)
  • Commerce Ministry brings export of medical devices, pharma machinery under EEPC (PharmaBiz)
  • DCGI issues safety alert against use of Dendriatic cells for treatment of cancer (PharmaBiz)

Japan

  • Mitsubishi Tanabe's Hep C Drug Cited For 15 Deaths Since Japan Launch (PharmAsia-$)

Canada

  • Health Canada Eyes Moving Sunscreens Out Of Shadow Of Rx Regulation (Tan Sheet-$)
  • Canadian Review of Topical Antiseptics Finds Few Causes for Concern (Health Canada)

Other International

  • Baksheesh? Glaxo Allegedly Paid Bribes in Syria, too, a Report Says (Pharmalot) (Fierce) (Law 360-$)
  • Cost of hepatitis C treatment may be barrier for emerging markets (FT-$)

Clinical Trials

  • Timing of pre-dose baseline electrocardiograms in clinical trials: Increased sampling over a prolonged baseline period worsens variance of QTc (PubMed)

General Regulatory And Interesting Articles

  • Night light exposure could make breast cancer tumors tamoxifen resistant (MNT)
  • Cloud Pharmaceuticals raising $20M for its “in silico” approach to drug development (MedCity News)
  • Google X’s gigantic new project will try to map the healthy human body in its entirety (MedCity News)

Regulatory Reconnaissance #366 – 28 July 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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