Regulatory Focus™ > News Articles > Regulatory Recon: FDA Approves Female Libido Drug Addyi, With a Boxed Warning (19 August 2015)

Regulatory Recon: FDA Approves Female Libido Drug Addyi, With a Boxed Warning (19 August 2015)

Posted 19 August 2015 | By Michael Mezher 

Regulatory Recon: FDA Approves Female Libido Drug Addyi, With a Boxed Warning (19 August 2015)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Want to read Recon as soon as it's posted? Follow @Michael_Mezher and @RAPSorg on Twitter.

In Focus: US

  • FDA Approves Female Libido Drug With Boxed Warning (Press) (FDA) (BioPharmaDive) (MedCityNews) (NYTimes) (Washington Post) (Reuters) (WSJ) (NBC) (CBS) (SCRIP-$)
  • After Curing Hepatitis C, Gilead Works to Vanquish More Viruses (Bloomberg)
  • Keytruda Wins Expanded Melanoma Priority Review; Also A Delay (SCRIP-$)
  • AbbVie Requests Biosimilar Labeling Modification (FDA Life)
  • Clearing the Air on Pre-GDUFA Year 3 ANDAs; OGD Issues Revised (and Much Improved) Communications MAPP (FDA Law Blog)
  • Kicking off the PDUFA VI Reauthorization Process (FDA Voice)
  • FDA Revises 'Disruptive' Generics Communications Policies (SCRIP-$)
  • CDRH to Participate in IMDRF Regulated Product Submission Table of Contents Pilot (FDA)
  • FDA Announces Higher Fees for Export Certificates (FDA)
  • More scrutiny for Japanese duodenoscope makers on notification failures (FiercePharmaAsia)

In Focus: International

US: Pharmaceuticals and Biotechnology

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

  • Keytruda Wins Expanded Melanoma Priority Review; Also A Delay (SCRIP-$) (PMLive)
  • Bavarian Nordic initiates Phase 1 clinical trial of MVA-BN RSV vaccine (European Pharmaceutical Review)
  • Remedy Pharmaceuticals Initiates Phase 2A Study of CIRARA™ in Spinal Cord Injury (Press)
  • Aurobindo gets OK from FDA for Zyrtec generic (DSN)
  • Recently Listed Derma Firm Set for Phase III Acne Trial with NCE (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • Kicking off the PDUFA VI Reauthorization Process (FDA Voice)
  • FDA Revises 'Disruptive' Generics Communications Policies (SCRIP-$)
  • FDA Sets Lower Limits Than ISO For Endotoxins In Fluids Used In Intraocular Lens Surgeries (Gray Sheet-$)
  • Patent Reform Should Not Bailout Big Drug Companies (Forbes)
  • GlaxoSmithKline Re-opens Plant Where Legionnaires' was Found (PharmPro)

US: Medical Devices                                                                                                                                      

  • CDRH to Participate in IMDRF Regulated Product Submission Table of Contents Pilot (FDA)
  • FDA Announces Higher Fees for Export Certificates (FDA)
  • More scrutiny for Japanese duodenoscope makers on notification failures (FiercePharmaAsia)
  • Corrosion Testing for Nickel Stents Front And Center In FDA Final Update (Gray Sheet-$)
  • FDA unveils pilot program for reporting medical device malfunctions (FierceMedicalDevices) (Focus)
  • US Regulators Extend UDI Deadlines Following Security Issue (MassDevice)
  • Death prompts Class I recall of Western/Scott Fetzer’s OxyTote portable oxygen system (MassDevice)
  • Philips' Lumify To Enable High-Quality Ultrasound Via Smart Device (Gray Sheet-$)
  • The Faster FDA Gets, the More Data it Needs (MDDI)
  • Opening the Black Box: What Happens to Your 510(k) Once It Reaches FDA (MDDI)
  • FDA Approves GE's Low-Dose CT Device For Lung Cancer Screening (MedDeviceOnline)
  • 3D-Printed Stethoscope Costs 30¢ To Make, Outperforms "Gold Standard" (MedDeviceOnline)
  • Commercial brain stimulation device impairs memory (MNT)

US: Assorted and Government

  • 14 Execs Charged with Selling $78M in Counterfeit, Mislabled Drugs (PharmPro)
  • $10K Fine Accompanies Illegal Skin Condition Drug Distribution (PharmPro)

Upcoming Meetings and Events              

Europe

  • HRA must continue ‘progress towards clinical trial transparency’ (Pharmafile)
  • Rawlins: Seek More Joint Scientific Advice for your PIMs (SCRIP-$)
  • CHMP recommends label update for Giotrif (Press)
  • Kythera files for EU approval of “double-chin” treatment (PharmaLetter-$)
  • Cellexus chasing emerging bacteriophage sector with new bioreactor (BioPharma-Reporter)

Canada

  • Canada approves Alexion's enzyme replacement therapy Strensiq (SCRIP-$)

India

China

Ebola Outbreak

  • Rapid paper-strip test for Ebola in sight (MNT)

Other International

  • Does South Korea Need A State-Owned Pharma To Stabilize Supply? (PharmAsiaNews)
  • WHO Director-General addresses traditional medicine forum (WHO)

General Health and Other Interesting Articles

Regulatory Reconnaissance #621 – 19 August 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 @Michael_Mezher 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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