Regulatory Focus™ > News Articles > Regulatory Recon: FDA Reopens Comment Period on Social Media Guidance (26 September 2014)

Regulatory Recon: FDA Reopens Comment Period on Social Media Guidance (26 September 2014)

Posted 26 September 2014 | By Alexander Gaffney, RAC

Regulatory Recon: FDA Reopens Comment Period on Social Media Guidance (26 September 2014)

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

This fall, regulatory professionals from across the globe will come together to learn, connect and share at the Regulatory Affairs Professionals Society’s  2014 RAPS: The Regulatory Convergence, 27 September-1 October, Austin, TX.   Register here, or check out some of the most news-worthy sessions here.

In Focus: US

  • FDA Re-Opens Comment Period on Social Media Guidances ( FDA) ( FDA)
  • FDA/EU Mutual Reliance For GMP Inspections Moving Forward ( Pink Sheet-$)
  • New FDA "Emerging Technology Team" to Spur Modern Drug Manufacturing ( PharmTech Talk)
  • Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD ( Pharma Letter-$) ( SCRIP-$) ( MedPage Today) ( Pharma Times)
  • Eric Holder questions marijuana's legal status as he prepares to leave Justice Department ( Vox)
  • UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind? ( Gray Sheet-$) ( Clinica-$)
  • First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance ( Gray Sheet-$)
  • Too little research supports newer joint implants: study ( Reuters)
  • EPA targets dental fillings ( The Hill)
  • FDA To Allow More Input Amid Informed Consent Uproar ( Law 360-$) ( FDA)
  • FDA Opening New Biodefense Lab Complex Today ( WaPo)

In Focus: International

  • Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use ( EMA)
  • EMA releases New Batch of CHMP Decisions ( EMA)
  • Gilead’s Hepatitis C Combination Wins EU Agency Backing ( Bloomberg) ( Press) ( EMA) ( Fierce)
  • GSK Aftermath: Industry Grapples With Compliance Issues ( PharmAsia-$) ( SCRIP-$)
  • Australia Refuses To Reimburse Gilead's Sovaldi ( PharmAsia-$)
  • European Medicines Agency Calls Out to Companies Developing Ebola Treatments ( PharmExec) ( Reuters) ( EMA)
  • Ebola Shot Turned Down by WHO Is Best Hope as Virus Rages ( Bloomberg)
  • Indian industry decries 'smear campaign' against its pharma exporters ( Pharma Letter-$)

US: Pharmaceuticals and Biotechnology

  • FDA Re-Opens Comment Period on Social Media Guidances ( FDA) ( FDA)
  • FDA/EU Mutual Reliance For GMP Inspections Moving Forward ( Pink Sheet-$)
  • New FDA "Emerging Technology Team" to Spur Modern Drug Manufacturing ( PharmTech Talk)
  • Boehringer’s Spiriva Respimat OKed by FDA for maintenance treatment of COPD ( Pharma Letter-$) ( SCRIP-$) ( MedPage Today) ( Pharma Times)
  • FDA Seeks New Division Director for Division of Oncology Products ( Indeed)
  • NIH and FDA Win Top Award for Intellectual Property Licensing of Meningitis Vaccine ( Press)
  • U.S. Illnesses and Deaths Associated With Compounded Medications ( Pew)
  • Genzyme Sues To Stop Generic Leukemia Drug Application ( Law 360-$)
  • What Actavis Did Not Want You to See in That Antitrust Lawsuit ( Pharmalot)

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

  • AcelRx Seeks Refiling of NDA in 2015 ( Press)

US: Pharmaceuticals and Biotechnology: General

  • Eric Holder questions marijuana's legal status as he prepares to leave Justice Department ( Vox)
  • Top 100 US Drug Pricing Average Jumps Seven-Fold to $9,400 in 2014 ( Press)
  • Biologicals and orphan diseases spark huge increases in US drug prices ( EP Vantage) ( Fierce)
  • Soligenix nabs up to $24.7M NIH contract for bioterror vaccine ( Fierce)
  • Schumer urges DEA to ban synthetic drugs ( The Hill)
  • DEA: Vicodin, Some Other Pain Meds Will Be Harder to Get ( Kaiser)

US: Medical Devices

  • UDI Milestone: Unique Identifiers Now Required For Class III Devices – But Are Some Firms Lagging Behind? ( Gray Sheet-$) ( Clinica-$)
  • First Glucose Meter Cleared For Hospital ICUs As FDA Continues Work On Guidance ( Gray Sheet-$)
  • Too little research supports newer joint implants: study ( Reuters)
  • Ophthalmic Panel To Eye Alcon’s AcrySof IQ Restor Multifocal IOL ( Gray Sheet-$) ( FDA)
  • EPA targets dental fillings ( The Hill)
  • Industry Urges FDA To Codify Device Data System Enforcement Discretion ( IHP-$)
  • Ramping Up Medical Device Cybersecurity ( GovInfoSec)
  • 5 Best Practices for Successful GUDID Submissions ( MDDI)
  • Submissions for Early Growth Response 1 Gene Fluorescence In-Situ Hybridization Test System for Specimen Characterization Devices; Draft Guidance for Industry and Food and Drug Administration Staff; Availability ( FDA)
  • Volunteers use 3D printers to create inexpensive prosthetics ( Mass Device) ( Reuters)
  • Clear Guide Medical Receives FDA 510(k) Clearance on First Product, the CLEAR GUIDE ONE ( Press)

US: Dietary Supplements

  • Authorities Seize Botanical Kratom, FDA Files Lawsuit ( NPI) ( FDA)
  • FDA’s NDI Guidance—No Greater Controversy in DSHEA’s 20 Years ( NPI)

US: Assorted And Government

  • FDA To Allow More Input Amid Informed Consent Uproar ( Law 360-$) ( FDA)
  • FDA Opening New Biodefense Lab Complex Today ( WaPo)
  • Walter Harris: FDA Eyes New CIO Hire Within 90 Days ( Government Executive)
  • Regulatory Underpinnings of Global Health Security: FDA's Roles in Preventing, Detecting, and Responding to Global Health Threats ( PubMed)
  • Weekly FDA Enforcement Report ( FDA)
  • CBO Scores Cost of DEA Scheduling Reform Bill ( CBO)
  • FDA's Priceless Response to a Stupid FOIA Request ( Gizmodo)

Upcoming Meetings

Ebola Outbreak

  • European Medicines Agency Calls Out to Companies Developing Ebola Treatments ( PharmExec) ( Reuters) ( EMA)
  • Ebola Shot Turned Down by WHO Is Best Hope as Virus Rages ( Bloomberg)
  • Fujifilm Says French Ebola Patient Taking Its Avigan Drug ( Bloomberg)
  • US doc treated with Tekmira Ebola drug declared virus free ( BioPharma Dive) ( Reuters) ( NBC) ( CBS) ( SCRIP-$)
  • Canada says poor coordination bogging down Ebola vaccine shipment ( Reuters)

Europe

  • Patients to discuss benefit-risk evaluation of medicines with the Committee for Medicinal Products for Human Use ( EMA)
  • EMA releases New Batch of CHMP Decisions ( EMA)
  • Gilead’s Hepatitis C Combination Wins EU Agency Backing ( Bloomberg) ( Press) ( EMA) ( Fierce)
  • EU agency backs Almirall lung drug being bought by AstraZeneca ( Reuters) ( BioCentury)
  • Navidea’s Lymphoseek Recommended by CHMP for European Approval in Sentinel Lymph Node Detection for Melanoma, Breast and Certain Head and Neck Cancers ( Press)
  • BI's Nintedanib receives positive CHMP opinion for second-line treatment of patients with adenocarcinoma of the lung ( Press)
  • AstraZeneca says expanded use of lung cancer drug backed by EU agency ( Reuters) ( Press) ( Pharma Times)
  • Novartis drug Signifor LAR recommended by CHMP for EU approval to treat patients with rare hormonal disorder acromegaly ( Press) ( Reuters)
  • European Parliament names new shadow rapporteur on IVD file ( Clinica-$)
  • EMA confirms positive benefit-risk for antidepressant Valdoxan/Thymanax (agomelatine) ( EMA)
  • UK’s MHRA Pediatric Drug Reporting Focuses on Severe Events ( FDA News-$) ( MHRA)
  • German drug law has cut top-sellers' prices by 23%, say health funds ( Pharma Times)
  • France Hardly Prescribes any Generic Drugs ( EurActiv)
  • Doctors lead backlash against expensive cancer drugs ( FT-$)

India

  • Indian industry decries 'smear campaign' against its pharma exporters ( Pharma Letter-$)
  • Indian PM’s Balancing Act: Patents Or Access To Meds? ( PharmAsia-$)
  • Human albumin serum not available across India post NPPA price cut ( PharmaBiz)

China

  • GSK Aftermath: Industry Grapples With Compliance Issues ( PharmAsia-$) ( SCRIP-$)
  • China's potent answer to Viagra ( ECNS)
  • China FDA Warns Of Serious Propylthiouracil Adverse Reactions ( PharmAsia-$)

Japan

  • Eisai Submits Application In Japan For Indication Expansion Of Vascular Embolization Device Dc Bead To Include Treatment Of Hypervascularized Tumors And Arteriovenous Malformations ( Press)

Canada

  • miacom diagnostics GmbH announces Health Canada Approval for hemoFISH assays, a platform technology to analyze positive blood cultures in 30 minutes ( Press)

Australia

  • Australia Refuses To Reimburse Gilead's Sovaldi ( PharmAsia-$)

Other International

  • AHWP Releases New Document, Adverse Reporting Timelines Guidance for Medical Device Manufacturer and its Authorized representative ( AHWP)

Regulatory Reconnaissance #408 – 26 September 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.

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.


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