Regulatory Recon: Tom Abrams on FDA's New Social Media Guidance (25 June 2014)

Posted 25 June 2014

By Alexander Gaffney, RAC

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

In Focus: US

• Tom Abrams Talks Social Media Guidances (PharmExec)
• FDA Drug Approval Times Plunging (MedCityNews)
• FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection (Tan Sheet-$)
• FDA Ends Olmesartan Safety Review, But no Clear Answers Emerge (Forbes) (FDA) (FDA)
• CDRH Looks To Reduced Confidence Intervals To Support Expedited-Access Program (Gray Sheet-$)
• House panel discusses putting patients in control of health information (Fierce) (Modern Healthcare) (SCRIP-$)

In Focus: International

• How EMA has been able to get adaptive licensing off the ground ahead of FDA (BioCentury-$)
• Lilly Rejects NICE Comparator For Efient In ACS, But Gains Approval Anyway (Pink Sheet-$)
• Indian health minister on US tie-strengthening trip (SCRIP-$)
• A Systematic Review of Cohort Studies of Clinical Trials (PLoS)

US: Pharmaceuticals and Biotechnology

• Tom Abrams Talks Social Media Guidances (PharmExec)
• FDA Drug Approval Times Plunging (MedCityNews)
• FDA Faults BASF Sunscreen Ingredient Data In Latest TEA Rejection (Tan Sheet-$)
• FDA Ends Olmesartan Safety Review, But no Clear Answers Emerge (Forbes) (FDA) (FDA)
• Overview of Recently Approved 505(b)(2) New Drug Applications (2010-2012): Role of Clinical Pharmacology (PubMed)
• A testing strategy to predict risk for drug-induced liver injury in humans using high-content screen assays and the 'rule-of-two' model (PubMed)
• Adverse Outcome Pathways: From Research to Regulation Workshop; Notice of Public Meeting and Registration Information (NIH)
• Accelerated Approval Seen As Coming Up Short For Rare Disease Drugs (IHP-$)
• Stirring the Pot of AIA Alphabet Soup: Now that Hatch-Waxman IPR Challenges Are Passé, Are PTAB CBM Patent Challenges the Next Big Thing? (FDA Law Blog)
• Genzyme offers inside look at Massachusetts plant under consent decree (BioPharma Reporter)
• Ex-Mylan VP Says He Was Axed Over Cephalon FCA Whistleblowing (Law 360-$)
• Proposed Revised Vaccine Information Materials for Td, Tdap, Haemophilus influenzae type b, and Rotavirus Vaccines (CDC)
• Niaspan Antitrust Injury Is 'Pure Speculation,' Judge Told (Law 360-$)
• Dr. Reddy's Launches Generic Zemplar Capsules (India Times)

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

• BMS halts trial early on melanoma survival benefit (Pharma Times) (BMS) (Fierce) (BioCentury) (Pharmafile)
• Aerie Pharma's combo eye drug succeeds, shares soar (Reuters)
• Basilea Gets FDA Request for More Data on Pneumonia Drug (Bloomberg)

US: Pharmaceuticals and Biotechnology: General

• Report: IOM Report Used as Basis of Popular Pain Statistic Did not Disclose Conflicts of Interest (MedPage Today)
• Reimbursement Considerations for Early Stage Companies (BIO)

US: Medical Devices

• CDRH Looks To Reduced Confidence Intervals To Support Expedited-Access Program (Gray Sheet-$)
• House panel discusses putting patients in control of health information (Fierce) (Modern Healthcare) (SCRIP-$)
• Revision total hip and knee arthroplasty implant identification: implications for use of Unique Device Identification 2012 AAHKS member survey results (PubMed)
• 3-D mammography substantially improves screening for breast cancer, new study shows (WaPo) (NPR) (NBC)
• The FDA may ban the treatment keeping our daughter alive (WaPo)
• Rejected Lyme Tests (NECIR)
• Qiagen wins FDA OK for organ transplant test (Fierce)

US: Dietary Supplements

• Dietary Supplement Manufacturer Audit Preparation (NPI)
• Doctor’s Best Issues Voluntary Nationwide Recall of Red Yeast Rice due to Undeclared Lovastatin (FDA)

US: Assorted And Government

• Sylvia Mathews Burwell Sworn In as the New HHS Secretary (White House)
• Soul-crushing regulations: How bureaucrats are chasing smart young entrepreneurs out of HIT (MedCityNews)
• Why Do FDA Agents Have Guns? (Politix)

Europe

• How EMA has been able to get adaptive licensing off the ground ahead of FDA (BioCentury-$)
• Lilly Rejects NICE Comparator For Efient In ACS, But Gains Approval Anyway (Pink Sheet-$)
• UK Data authority chair calls for pharma transparency (Pharmafile)
• Where have EU notified bodies been going wrong? The latest (Clinica-$)
• Abbott tallies E.U. win for next-gen intraocular lenses (Mass Device) (Mass Device)

India

• Indian health minister on US tie-strengthening trip (SCRIP-$)
• Industry: Indian pharma needs to invest in operational excellence to ensure regulatory compliance (PharmaBiz)

Japan & China

• Astellas Files Application for Certolizumab Pegol in Japan (Astellas)
• The Bruker MALDI Biotyper Receives Clearance as a Medical Device from the China Food and Drug Administration (CFDA) (Press)
• Aesica plant in Italy responds as China's track and trace rules come into play (Fierce)

Canada

• Minister Ambrose Launches Advisory Panel on Healthcare Innovation (Press)

Other International

• Waiting for ICH Q3D (Step 4): Revision and Implementation of national Regulations delayed! (ECA)
• Australia: Manufacturing methods blamed for flu jab fits in children (The Australian)

Clinical Trials

• Evidence for the Selective Reporting of Analyses and Discrepancies in Clinical Trials: A Systematic Review of Cohort Studies of Clinical Trials (PLoS)

General Regulatory And Interesting Articles

• A New Paradigm for Achieving Regulatory Compliance (PharmaManufacturing)

Regulatory Reconnaissance #344 – 25 June 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.

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