Regulatory Focus™ > News Articles > Regulatory Recon: FDA Oversight of Dietary Supplements Scrutinized (7 April 2015)

Regulatory Recon: FDA Oversight of Dietary Supplements Scrutinized (7 April 2015)

Posted 07 April 2015 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Oversight of Dietary Supplements Scrutinized (7 April 2015)

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

In Focus: US

  • Some Popular Supplements Still Contain Untested Compound (LiveScience) (Tan Sheet-$) (NI-USA)
  • What's Next For The Thousands Of Angry Men Suing Over Testosterone? (Forbes)
  • Drug side effects? There’s an app for that (FedScoop)
  • Why Drugs Get Delayed: Blame It On Safety Concerns, Researchers Say (Pink Sheet-$)
  • FDA approves breath test to aid in diagnosis of delayed gastric emptying (FDA)
  • FDA Regulation of Personal Lubricants (FDA Attorney)

In Focus: International

  • Indian Health ministry reconstitutes Drugs Technical Advisory Board (PharmaBiz)
  • New Barcoding Track and Trace Policy Takes Effect in India (FDAnews-$)
  • China Needs More Drugs (OZY)
  • IMDRF Releases Three New Consultations (IMDRF)
  • Refining UK market access (Pharmafile)

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US: Pharmaceuticals and Biotechnology

  • What's Next For The Thousands Of Angry Men Suing Over Testosterone? (Forbes)
  • Drug side effects? There’s an app for that (FedScoop)
  • Why Drugs Get Delayed: Blame It On Safety Concerns, Researchers Say (Pink Sheet-$)
  • A Novel Patient Support Program to Address Isotretinoin Adherence: Proof-of-Concept Analysis (PubMed)
  • FDA Expands Qudexy XR Monotherapy Age Range (MPR)

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

  • Alkermes heads to Phase III with a schizophrenia drug designed to spare the waistline (Fierce)
  • Ocular Therapeutix plunges as eye treatment blurs the line in PhIII (Fierce) (The Street) (Press)
  • Merck’s Revised Biosimilar Strategy Poised To Deliver (Pink Sheet-$)
  • Clovis gets breakthrough status for ovarian cancer drug (AP) (BioCentury)
  • Shire Announces Clear Regulatory Path Forward for SHP465, an Investigational Treatment for Adults with ADHD (Press) (Pharmafile)
  • Oncolytics Biotech Inc. Announces Filing for Orphan Drug Designation with the U.S. FDA for Gastric Cancer (Press)
  • Pfizer PhIII Clinical Trial Delayed by Supply Issues (Press)

US: Pharmaceuticals and Biotechnology: General

  • Why are Clinicians Reluctant to Prescribe PrEP to High-Risk Patients? (MPR)
  • NCATS chases crystal balls to predict drugs' futures (SCRIP-$)

US: Medical Devices

  • FDA approves breath test to aid in diagnosis of delayed gastric emptying (FDA)
  • FDA Regulation of Personal Lubricants (FDA Attorney)
  • The Cost of Inaccurate Mammograms: $4 Billion (NBC) (CNBC)
  • Requests for Nominations: Advisory Committee on Medical Uses of Isotopes (NRC)
  • Drug test manufacturer seeking FDA approval for new product (BizJournal)

US: Dietary Supplements

US: Assorted And Government

  • Seized counterfeits goods in US dip to $1.2bn in 2014 (Securing Industry)
  • FDA's 2015 Office of Regulatory Science and Innovation Science Symposium (FDA)
  • NIH Releases National Pain Strategy (NIH)

Upcoming Meetings and Events

Europe

  • Refining UK market access (Pharmafile)
  • Classification of Medicines - 2014 Edition of Resolution ResAP(2007)1 now available (EDQM)
  • New NICE Guidance on VibraTip for the Detection of Diabetic Peripheral neuropathy (NICE)
  • CTD Holdings Obtains European Orphan Drug Designation for Trappsol Cyclo (Press)
  • Cytori Granted Orphan Drug Status for Cellular Therapeutic in European Union (Press)

India

  • Indian Health ministry reconstitutes Drugs Technical Advisory Board (PharmaBiz)
  • New Barcoding Track and Trace Policy Takes Effect in India (FDAnews-$)
  • India OKs Abbott's FreeStyle Libre Pro glucose monitoring system (Mass Device)

China

  • China Needs More Drugs (OZY)

Canada

  • Health Canada warns of side-effects from hepatitis C-heart drug combo (Vancouver Sun)

Other International

  • IMDRF Releases Three New Consultations (IMDRF)

General Regulatory And Interesting Articles

  • Cancer Mortality Reductions Were Greatest Among Countries Where Cancer Care Spending Rose The Most, 1995–2007 (Health Affairs)
  • Oral Antibiotics Are Found to Save More Infant Lives (NYTimes)
  • Endo Apps: The DIY Artificial Pancreas (MedPage Today)
  • The oldest medical consent form has been uncovered – it comes way back from 1524 (MedCityNews)

Regulatory Reconnaissance #530 – 7 April 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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