Regulatory Focus™ > News Articles > Regulatory Reconnaissance: Senate to FDA: What's up With These Draft Guidances? (8 May 2014)

Regulatory Reconnaissance: Senate to FDA: What's up With These Draft Guidances? (8 May 2014)

Posted 08 May 2014 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Senate HELP Committee Asks FDA to Explain its Use of Draft Guidances (FDA Law Blog)
  • FDA Ties Brisdelle Approval To Unmet Need For Hormone-Free Therapy (Pink Sheet-$) (NEJM)
  • Another Recall for Hospira Due to Metal Particles (FDA) (FDA)
  • Massachussetts defends new restrictions for painkiller (AP)
  • FDA Drug Chief: Drug Cures Progress Could Require 'Down Payment' (IHP-$)
  • Murder: Another Ambien Side Effect? (MedPage Today)
  • Shuren Highlights CDRH Actions To Ease Trial Burdens On Capitol Hill (Gray Sheet-$)
  • St. Jude Medical Says DOJ Probing Potential FCA Violations (Law 360-$)

In Focus: International

  • EMA reports new pharmacovigilance legislation meeting expectations (In-Pharma)
  • EMA: Draft guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies (EMA)
  • Santhera resubmits Raxone MAA (BioCentury) (Pharma Letter-$) (SCRIP-$)
  • China reports medical equipment deaths (People's Daily)
  • China To End Price Caps on 530 Drugs, Citing Quality, Shortage Problems (PharmAsia-$) (Bloomberg)
  • How to Use Regulatory Operations as a Competitive Advantage in Emerging Markets (MDDI)
  • Australia Takes Similar Approach to 23andMe as US FDA (Reuters)

US: Pharmaceuticals/Biotechnology

  • FDA Ties Brisdelle Approval To Unmet Need For Hormone-Free Therapy (Pink Sheet-$) (NEJM)
  • Another Recall for Hospira Due to Metal Particles (FDA) (FDA)
  • Massachussetts defends new restrictions for painkiller (AP)
  • FDA Drug Chief: Drug Cures Progress Could Require 'Down Payment' (IHP-$)
  • Murder: Another Ambien Side Effect? (MedPage Today)
  • Sun Pharma Recalling 160,000 bottles of antidepressant (India Times)
  • Report: FDA Lacks "Adequate Policy" for Regulating Medications Which Increase Blood Pressure (PubMed)
  • No End In Sight For Nationwide Shortage of Saline Solution (CBS)
  • New MAPP for Drug Safety Oversight Board (FDA)

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

  • Takeda presents Phase III data for TAK-438 (BioCentury)
  • Corcept tanks as depression drug comes up short in Phase III (Fierce) (Reuters) (Reuters) (SCRIP-$)
  • New Drug Combination Highly Effective For Hepatitis C (Forbes)
  • Biota says U.S. agency terminates funding for flu drug (Reuters)
  • US: Pharmaceuticals and Biotechnology: General
  • Study: Despite Lacking FDA Indication, Diuretics Given to Many Infants (PubMed)
  • Legal rights advocacy group: States should stick to FDA-approved drugs for execution (Reuters)
  • Federal agents target synthetic drugs, sellers (AP) (Reuters) (The Hill)

US: Medical Devices

  • Shuren Highlights CDRH Actions To Ease Trial Burdens On Capitol Hill (Gray Sheet-$)
  • FDA Panel Supports Down-Classification For ECMO Circuits (Gray Sheet-$)
  • FDA Safety Communication: Removing Retrievable Inferior Vena Cava Filters (FDA) (FDA)
  • FDA says Biotronik's pacemakers are MRI-friendly (Mass Device) (Press)
  • St. Jude Medical Says DOJ Probing Potential FCA Violations (Law 360-$)
  • FDA's Former Director of Device Compliance Joins Industry (Press)
  • FDA Sends Custom Device Exemption Guidance to OMB (FDA)
  • FDA warns Cook Medical on unapproved changes to Evolution lead extractor (Mass Device)
  • Baxter Receives 510(k) Clearance for Next-Generation SIGMA Spectrum Infusion Pump with Master Drug Library (Press)
  • BD MAX Enteric Bacterial Panel Receives FDA Clearance to Detect the Most Common Causes of Bacterial Gastroenteritis (Press)
  • St. Jude Medical Announces TOCCASTAR Clinical Trial Meets Primary Safety and Efficacy Endpoints (Press)
  • April 2014 510(k) Clearances (FDA)

US: Assorted And Government

  • Senate HELP Committee Asks FDA to Explain its Use of Draft Guidances (FDA Law Blog)
  • Transcend Compliance, Realize Greatness (PCM)
  • Mini-Sentinel Develops Outline of Two-Phase Study Design (FDA)
  • Mini-Sentinel Develops Algorithmic Approach to Identifying Cohorts Unlikely to Benefit from Treatment (FDA)
  • BIO and ViS Research Expand Research Site Group to Help Streamline Pediatric Clinical Trials (Press)
  • Fostering innovation, advancing patient safety: the kidney health initiative. (PubMed)
  • Latest FDA Enforcement Report (FDA)

Europe

  • EMA reports new pharmacovigilance legislation meeting expectations (In-Pharma)
  • EMA: Draft guideline on the role of the pathological Complete Response as an endpoint in neoadjuvant breast cancer studies (EMA)
  • Santhera resubmits Raxone MAA (BioCentury) (Pharma Letter-$) (SCRIP-$)
  • AbbVie files hepatitis C combo in Europe (PharmaTimes) (Press)
  • EU looks at eye drug allegations (Pharmafile)
  • European Medicines Agency closed 9 May 2014  (EMA)
  • GTx Says Muscle-Wasting Treatment Faces Mixed Regulatory Prospects (WSJ-$)

Japan & China

  • China reports medical equipment deaths (People's Daily)
  • China To End Price Caps on 530 Drugs, Citing Quality, Shortage Problems (PharmAsia-$) (Bloomberg)
  • China FDA to Sign MOU With Nigerian Counterparts (Turkish Press)

Other International

  • How to Use Regulatory Operations as a Competitive Advantage in Emerging Markets (MDDI)
  • Australia Takes Similar Approach to 23andMe as US FDA (Reuters)
  • Conservative Activists Want Health Canada not to Approve Abortion Pill RU-486 (The Sun)
  • Australia: Uniform recall procedure for therapeutic goods (URPTG) (TGA)

General Regulatory And Interesting Articles

  • Scientists Add Letters to DNA's Alphabet, Raising Hope and Fear (NYTimes) (Bloomberg)

Regulatory Reconnaissance #314 - 8 May 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.

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe