Regulatory Focus™ > News Articles > Regulatory Reconnaissance (7 October 2013)

Regulatory Reconnaissance (7 October 2013)

Posted 07 October 2013 | By Alexander Gaffney, RAC

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Oddly lopsided day for news-lots on the US front, and almost nothing outside of it. Got anything we might be interested in sharing? Let us know: news@raps.org.

In Focus: US

  • Pharmaceutical firms paid to attend meetings of panel that advises FDA (Washington Post) (MedPage Today)
  • Labs that test safety of custom-made drugs fall under scrutiny (Washington Post)
  • Shutdown halts federal rulemaking processes (The Hill)
  • House of Representatives Passes Bill to End FDA Shutdown (Bill) (CBO) (The Hill)
  • Mixed ruling in drug firms' fight to keep secret violations under CIAs (Politico) (Ruling)
  • FDA Quality Grades Could Leave Drugmakers Smarting (Law 360-$) (Tan Sheet-$)
  • Ranbaxy hunts for FDA-okayed plants in India to get Around Import Ban (Economic Times)
  • FDA's Final UDI Rule: A Few Tricks But Mostly Treats (MDDI)
  • FDA concerns lead Atossa Genetics to pull breast health device from the market (MedCity News) (FDA) (Reuters)

In Focus: International

Comments? Suggestions? Email me at news@raps.org.

US: Pharmaceuticals/Biotechnology

  • Pharmaceutical firms paid to attend meetings of panel that advises FDA (Washington Post) (MedPage Today)
  • Labs that test safety of custom-made drugs fall under scrutiny (Washington Post)
  • Mixed ruling in drug firms' fight to keep secret violations under CIAs (Politico) (Ruling)
  • FDA Quality Grades Could Leave Drugmakers Smarting (Law 360-$) (Tan Sheet-$)
  • Ranbaxy hunts for FDA-okayed plants in India to get Around Import Ban (Economic Times)
  • Pharmaceutical Industry Scrambles to Fast-Track Drugs (Scientific American)
  • Top manufacturers seek clarity on delaying, denying FDA inspections (In-Pharma)
  • CBER Focus Intensifying on Export Certification, Adverse Event Databases, and Lab Help in Product Development (IPQ-$)
  • Does Novartis' Gilenya Twitter Account Fall Afoul of FDA Regulations? (Pharma Marketing)
  • Should Drugmakers Pay Punitive Damages? Novartis Says No (Pharmalot)
  • On the one year anniversary of implementation of the Prescription Drug User Fee Act (PDUFA V), what element has shown the most promise? (PhRMA)
  • Generics Of Abuse-Deterrent Opioids Will Get FDA Guidance, Eventually (Pink Sheet)
  • FDA In Twilight: Gov't Shutdown Has Not Slowed Rx Operations Too Visibly Yet (Pink Sheet-$) (PMLive) (BioCentury)
  • "Patient Voice" Report Puts Chronic Fatigue Symptoms, Treatments In Benefit/Risk Framework (Pink Sheet-$)
  • Narcolepsy Meeting Focuses On Symptoms, But Some Urge Attention To Underlying Cause (Pink Sheet-$)
  • Is Part 11 Dead? Part 1 of a series- Electronic Records (Lachman Consultants)
  • The Dynamic Evolution of Multi-sponsor REMS (PPD)
  • Andrea Sloan, 'Poster Child' For Compassionate Use, Gets A Drug (Pharmalot)
  • Hospira Issues A Voluntary Nationwide Recall Of One Lot Of 1% Lidocaine HCL Injection Due To The Presence Of Dark Particulate (FDA)
  • FDA Posts New 483 to Compounding Pharmacy (FDA)
  • Discovery Labs shares rise on news that new drug Surfaxin is cleared for U.S. launch (Reuters) (Pharma Letter-$) (SCRIP-$)
  • GT Biologics Granted FDA Orphan Designation for Lead Product (Press)
  • Cornerstone pharmaceuticals receives FDA orphan drug designation of CPI-613 for treatment of myelodysplastic syndrome (MNT)
  • C-Path cosponsors Alzheimer's workshop (C-Path)
  • Track and Trace: California, Congress and The Choices We Are Forced To Face (RxTrace)
  • In late-stage study, Novartis finds asthma drug effective at reducing itch from hives (Reuters) (Pharma Letter-$) (Pharma Times) (PMLive)
  • SCRIP's US Capitol Capsule (SCRIP-$)

US: Pharmaceuticals and Biotechnology: General

  • US Government Establishes Fill-Finish Network (PharmTech) (DHHS) (Biopharma Reporter)
  • One year later, effects of the 2012 national meningitis outbreak still linger (MedCity News)
  • Tenn. meningitis relapse case draws attention (ModernHealthcare) (USA Today)
  • Are $300K Drugs Disruptive To The Healthcare System? (Forbes)
  • Making CER Findings Relevant Requires Putting Results In Context - PCORI Board (Pink Sheet-$)
  • Opioid Abuse-Deterrent "Holy Grail" Still A Ways Off; Will Industry Invest For That Long? (Pink Sheet-$)
  • Doxil shortage looms as Boehringer announces plant closure (Pharma Times)

US: Medical Devices

  • FDA's Final UDI Rule: A Few Tricks But Mostly Treats (MDDI)
  • FDA concerns lead Atossa Genetics to pull breast health device from the market (MedCity News) (FDA) (Reuters)
  • Free the FDAAA Hostage (MDR Reporting)! (FDA Law Blog)
  • Echo Therapeutics slashes jobs, faces potential FDA delays for glucose monitor (Fierce)
  • Analysts: FDA May Finally Bless CardioMEMS' Wireless Technology Benefitting St. Jude (MDDI)
  • H&H Medical Corporation Issues Nationwide Recall of Emergency Cricothyrotomy Kit (FDA)
  • AliveCor gets FDA clearance for Android-compatible version (MobiHealthNews)
  • Esteya System for Skin Cancer Treatment Gets FDA 510(k) Clearance (MedGadget)

US: Assorted And Government

  • Shutdown halts federal rulemaking processes (The Hill)
  • House of Representatives Passes Bill to End FDA Shutdown (Bill) (CBO) (The Hill)
  • Shutdown Stalls US-EU Trade Agreement Talks (PharmExec)
  • Man's efforts help ensure drug trials nationwide go on despite shutdown (BizJournal)
  • Finding Clinical Trials During Government Shutdown (Polaris)
  • House approves back pay for furloughed workers (The Hill) (Federal Times)
  • Poll finds nearly half say regulation is too high (The Hill) (Poll)
  • Kratom Action Presents Regulatory Puzzle For FDA (Tan Sheet-$)
  • Could Shutdown Go Beyond October 17? (Strengthen FDA)
  • Drop in Federal Government Attendance at Meetings and Conventions Becoming a Trend (Policy and Medicine)

Upcoming Meetings And Events

  • October 8-9, 2013: Circulatory System Devices Panel of the Medical Devices Advisory Committee Meeting (FDA)
  • 9-10 October 2013: AAMI/FDA Summit on Healthcare Technology in Nonclinical Settings (AAMI)
  • 16 October 2013: Brookings Roundtable on Active Medical Product Surveillance (FDA)
  • Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

Asia

  • Relief as Apex Indian court seeks details on trial safeguards, stalling potential sector shutdown (SCRIP-$) (PharmaBiz) (BioSpectrum) (India Times)
  • New drugs & cosmetics regulation set to redefine medical devices in India (PharmaBiz)
  • India's Bliss Pharma denies FDA allegations of fake drugs (BioSpectrum)

Regulatory Reconnaissance #172 - 7 October 2013

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.

Did we miss a story? Send us a tweet at @RAPSorg and we'll check it out for inclusion in our next edition of Regulatory Reconnaissance. Want this in your inbox each morning? Sign up for RF Today, our morning intelligence newsletter here.

Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at news@raps.org.


Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe