Regulatory Focus™ > News Articles > Regulatory Recon: US Drug Shortages Drop, but Haven't Gone Away (9 April 2015)

Regulatory Recon: US Drug Shortages Drop, but Haven't Gone Away (9 April 2015)

Posted 09 April 2015 | By Alexander Gaffney, RAC 

Regulatory Recon: US Drug Shortages Drop, but Haven't Gone Away (9 April 2015)

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

In Focus: US

  • Are Shortages Going Down Or Not? Interpreting Data From The FDA And The University Of Utah Drug Information Service (HealthAffairs)
  • Public Citizen Scolds FDA for Denying Petition for Black Box Warning on ACE Inhibitors (Public Citizen)
  • FDA to Industry: Let’s Increase the Availability of Safe, Effective Animal Drugs (FDA Voice)
  • If You Can Believe the FDA Monthly Approvals Page – The Corner May be Further Down the Road for OGD (Lachman)
  • FDA's 'Critical-To-Quality' Inspectional Approach Might Not Extend To IMDRF Single-Audit Program (Gray Sheet-$)
  • Latex makers have mixed reactions to FDA advisory (Rubber & Plastics)
  • Fabricant Fires Back at NYTimes Over Supplement Story (NewHope)
  • UL debuts verification seal for dietary supplements (NI-USA)
  • Is faster better? Critics of House bill question risks of speeding FDA approval of drugs, devices (ModernHealthcare)

In Focus: International

  • Two New Ebola Vaccines Pass Important Early Test, Researchers Say (NYTimes) (SCRIP-$)
  • European Union Finally Joins MDSAP Work Group – But Only As Observer (Gray Sheet-$)
  • NICE Draft Guidance: What's in a Name - Is Final Really Final? (Context Matters)
  • Indian Health ministry to allow import of small quantities of drugs for personal use (PharmaBiz)
  • WHO to ignore powerful producers of substandard medicine (SearchingForSafety)
  • GMP Compliance: An Ounce Of Prevention (Thompson Reuters)
  • South Korea names first woman to head food and drug safety ministry (Fierce)

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US: Pharmaceuticals and Biotechnology

  • Are Shortages Going Down Or Not? Interpreting Data From The FDA And The University Of Utah Drug Information Service (HealthAffairs)
  • Public Citizen Scolds FDA for Denying Petition for Black Box Warning on ACE Inhibitors (Public Citizen)
  • FDA to Industry: Let’s Increase the Availability of Safe, Effective Animal Drugs (FDA Voice)
  • If You Can Believe the FDA Monthly Approvals Page – The Corner May be Further Down the Road for OGD (Lachman)
  • Judge Chides FDA For Stalling Otsuka's Abilify Suit (Law 360-$)
  • FDA Surveillance Team Finishes Work on Influenza Safety Surveillance Initiative (Mini-Sentinel)
  • 'Cosmeceutical' Classification In Regulatory Crosshairs (Law 360-$)
  • Oregon Right to Try Bill Passes House Committee (Press)
  • Aurobindo gets US FDA approval for anesthesia supplement drug product (Business Standard)
  • Trimming The Fat Off Of Post-Marketing Drug Safety (AdverseEvents)
  • FDA' s Advancing Regulatory Science: TRALI - Transfusion-Related Acute Lung Injury (ECA)
  • Colorado Governor Hickenlooper Signs Bill Ensuring Patient Access to Interchangeable Biologic Medicines (Press)

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

  • Merck Earns Back its Breakthrough Product Designation (BioCentury) (SCRIP-$)
  • Portola says it's ready to file 'breakthrough' anticoagulant antidote (Fierce) (BizJournal) (SCRIP-$)
  • Prolong Pharmaceuticals' Flagship Product SANGUINATE Granted Orphan Drug Designation by the FDA (Press)
  • Shire's SHP625 fails to meet primary or secondary endpoints in Alagille syndrome trial (PharmaLetter-$) (Press)
  • MedImmune's MEDI8897 Receives Fast Track Designation by the FDA for the Prevention of Respiratory Disease Caused by RSV in Infants (Press)
  • DBV Technologies Receives FDA Breakthrough Therapy Designation for Viaskin Peanut for the Treatment of Peanut Allergy in Children (Press)
  • Santhera receives FDA Fast Track Designation for Raxone/Catena (idebenone) for theTreatment of Duchenne Muscular Dystrophy (Press)
  • BioBlast Pharma Announces Granting of Fast Track Designation by the FDA for Cabaletta in Oculopharyngeal Muscular Dystrophy (OPMD) (Press)
  • Neurotrope Receives FDA Orphan Drug Designation for Bryostatin in the Treatment of Fragile X Syndrome (Press)

US: Pharmaceuticals and Biotechnology: General

  • American Cancer Society: Most US adults still not using sunscreen (Cosmetics Design)
  • Mylan Bids $29 Billion for Perrigo in Latest Big Pharma Deal (The Street)
  • Natco Aims to Become a Major Player in the US Generics Market (Bloomberg)
  • California bill banning child vaccine exemptions moves ahead (Reuters)

US: Medical Devices

  • FDA's 'Critical-To-Quality' Inspectional Approach Might Not Extend To IMDRF Single-Audit Program (Gray Sheet-$)
  • Latex makers have mixed reactions to FDA advisory (Rubber & Plastics)
  • Dem pushes for age limits on tanning beds (The Hill)
  • Proven Process Client Flowonix Medical Inc. Achieves FDA PMA(S) Approval Of Prometra II Infusion Device (Press)
  • Augmenix Announces FDA Clearance Of SpaceOAR System (Press)
  • FDA clears Synaptive Medical's "GPS for the brain" technology (Mass Device)
  • Germ-killing robots battle in court (ModernHealthcare)
  • Commport Aligns With Reed Tech To Provide Medical Device Manufacturers An Option For FDA GUDID Submissions (Press)

US: Dietary Supplements

  • Fabricant Fires Back at NYTimes Over Supplement Story (NewHope)
  • UL debuts verification seal for dietary supplements (NI-USA)
  • Interest in adverse event reporting post AG probe up 15-20%, say experts (NI-USA)
  • Lawsuits on the Horizon for Supplements Tainted With BMPEA (Press)

US: Assorted And Government

  • Is faster better? Critics of House bill question risks of speeding FDA approval of drugs, devices (ModernHealthcare)

Upcoming Meetings and Events

Ebola Outbreak

  • Two New Ebola Vaccines Pass Important Early Test, Researchers Say (NYTimes) (SCRIP-$)

Europe

  • European Union Finally Joins MDSAP Work Group – But Only As Observer (Gray Sheet-$)
  • NICE Draft Guidance: What's in a Name - Is Final Really Final? (Context Matters)
  • How much influence should patients have in drug approval recommendations? (SCRIP-$)
  • An EU-wide overview of the market of blood, blood components and plasma derivatives focusing on their availability for patients (EC)
  • Ph. Eur. Commission updates its Work Programme (EDQM)
  • Mobidiag C. difficile Test Receives CE Mark (GenomeWeb)
  • Added benefit of Vargatef depends on disease severity, says IQWiG (PharmaLetter-$)

India

  • Trickle To Deluge: India To See More Sovaldi Knock-Offs? (PharmAsia-$)
  • Health ministry to amend Form 12-B of D&C Rules to allow import of small quantities of drugs for personal use (PharmaBiz)
  • AIDCOC urges commerce ministry to hold drug regulators meet with SAARC countries on regular basis (PharmaBiz)

Other International

  • WHO to ignore powerful producers of substandard medicine (SearchingForSafety)
  • GMP Compliance: An Ounce Of Prevention (Thompson Reuters)
  • South Korea names first woman to head food and drug safety ministry (Fierce)

General Regulatory And Interesting Articles

  • Pfizer, Eli Lilly Were The Original Medical Marijuana Sellers (Forbes)
  • Cleveland startup’s nerve-stimulating device treats phantom pain stemming from amputation (MedCityNews)
  • Common painkiller may not ease lower back pain or osteoarthritis (Reuters)
  • Repurposed Allergy Drug Could Treat Hepatitis C (HealthLine) (NIH)
  • Researchers Working on Once-Per-Year HIV-Suppression Drug (NBC)
  • Microbes Engineered to Prevent Obesity (MIT Tech Review)
  • Erectile dysfunction drugs vary in effectiveness, side effects (Reuters)

Regulatory Reconnaissance #532 – 9 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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