Regulatory Focus™ > News Articles > Regulatory Recon: Speedy Drug Approvals the New Normal at FDA (1 May 2015)

Regulatory Recon: Speedy Drug Approvals the New Normal at FDA (1 May 2015)

Posted 01 May 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: Speedy Drug Approvals the New Normal at FDA (1 May 2015)

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

In Focus: US

  • Speedy Drug Approvals Have Become the Rule, Not the Exception (NYTimes)
  • FDA approves GSK's Asthma Drug Breo Ellipta for adults, not children (BioCentury) (Press) (Reuters) (Bloomberg)
  • FDA approves Raplixa to help control bleeding during surgery (FDA) (Press) (Fierce) (SCRIP-$) (Reuters)
  • FDA Nod for Vernalis cough/cold drug (PharmaTimes) (Press)
  • FDA Seeks Help in Building Statistically-Based Pharmaceutical Quality Standards (FDA)
  • New 21st Century Cures Act Removes Social Media Provision (RegulatoryRx)
  • Failing to Report Severe Drug Side Effects: A National Embarrassment (Forbes)
  • Industry’s Unofficial Training Ground: CDRH (MDDI)
  • FDA approves the Medicines Co's pain drug device Ionsys (Reuters)
  • ‘Cures’ Plan To Rely On 3rd-Party Audits For Some Device Changes Needs Tweaks, Shuren Says (Gray Sheet-$)
  • House Democrats want more FDA funding in medical innovation bill (ModernHealthcare) (SCRIP-$) (Pink Sheet-$)

In Focus: International

  • Where is the EU medical devices regulations revision? It’s complicated… (MedicalDevicesLegal)
  • GSK found UK's drug pricing changes a tough sell (PMLive)
  • Recommendations to Improve European Union Risk Management Plan Public Summaries (TIRS-$)
  • IMS Health Finds Wide Disparity Between Essential Medicines List of WHO and Several Pharmerging Countries (Press)

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US: Pharmaceuticals and Biotechnology

  • Speedy Drug Approvals Have Become the Rule, Not the Exception (NYTimes)
  • FDA approves GSK's Asthma Drug Breo Ellipta for adults, not children (BioCentury) (Press) (Reuters) (Bloomberg)
  • FDA approves Raplixa to help control bleeding during surgery (FDA) (Press) (Fierce) (SCRIP-$) (Reuters)
  • FDA Nod for Vernalis cough/cold drug (PharmaTimes) (Press)
  • FDA Seeks Help in Building Statistically-Based Pharmaceutical Quality Standards (FDA)
  • New 21st Century Cures Act Removes Social Media Provision (RegulatoryRx)
  • Failing to Report Severe Drug Side Effects: A National Embarrassment (Forbes)
  • Amgen Tells Fed. Circ. Sandoz Would 'Gut' Biosimilar Law (Law 360-$)
  • Judge Won't Block FDA's Generic Abilify Approvals (Law 360-$)
  • Pre–Investigational New Drug Meetings With the FDA: Evaluation of Meeting Content and Characteristics of Applications for New Drug and Biologic Products (TIRS-$)
  • It’s Been One of “Those Weeks” in Hatch-Waxman World: Another Two Lawsuits and Two Court Decisions (FDA Law Blog)
  • FDA Updates its Purple Book (FDA)
  • Multicriteria-Based Ranking Model for Risk Management of Animal Drug Residues in Milk and Milk Products (FDA)
  • Hospira's Rocky Mount warning letter lifted (Fierce)
  • HHS Says it Won't Consider Diabetes to be a Side Effect of the MMR Vaccine Under the VICP (HHS)
  • Oklahoma allows for use of marijuana derivative in medical trial (Reuters)

US: Pharmaceuticals and Biotechnology: General

  • Medicare Releases Detailed Data on Prescription Drug Spending (NYTimes) (WSJ-$) (MedPageToday) (WSJ-$) (KHN)
  • USTR Releases New Special 301 Report (KEI)
  • Pharma Frets as Local Governments Adopt Drug Take-Back Programs (Pharmalot)
  • Gilead first-quarter profit doubles on strong hepatitis C drug sales (Reuters) (NYTimes)
  • To Spur Medical Innovation, Make Corporate Cheaters Pay (Health Affairs)

US: Medical Devices

  • Industry’s Unofficial Training Ground: CDRH (MDDI)
  • FDA approves the Medicines Co's pain drug device Ionsys (Reuters)
  • ‘Cures’ Plan To Rely On 3rd-Party Audits For Some Device Changes Needs Tweaks, Shuren Says (Gray Sheet-$)
  • Top 5 Medical Device Trends That Will Dominate 2015 (GxP Lifeline)
  • Building a Mobile Medical App and Understanding FDA Regulatory Requirements (AAMI-$)
  • Two Congressmen Turn Up Heat on Power Morcellators (Medscape)
  • Guidelines for Medical Device Safety Testing – AAMI TIR62354:2015 (Eisner)
  • St. Jude gets FDA approval for tiniest MRI-compatible, upgradeable, spinal-cord pain neurostimulator (Fierce)
  • 4 medical device quality system musts for startups (MedCityNews)
  • Abbott grabs FDA OK for early pregnancy blood test (Fierce)
  • Many patients unaware of risks that go with some medical scans (Reuters)

US: Assorted And Government

Upcoming Meetings and Events

Ebola Outbreak

  • Host of Ailments Plague African Ebola Survivors (WSJ-$)

Europe

  • Where is the EU medical devices regulations revision? It’s complicated… (MedicalDevicesLegal)
  • GSK found UK's drug pricing changes a tough sell (PMLive)
  • Recommendations to Improve European Union Risk Management Plan Public Summaries (TIRS-$)
  • Advanced Inhalation Therapies Granted European Orphan Drug Designation for Nitric Oxide for the Treatment of Cystic Fibrosis (Press)

Other International

  • IMS Health Finds Wide Disparity Between Essential Medicines List of WHO and Several Pharmerging Countries (Press)

General Regulatory And Interesting Articles

Regulatory Reconnaissance #548 – 1 May 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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