Regulatory Reconnaissance: Indian Officials Say Hamburg to Visit India This Week (5 February 2014)

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In Focus: US

• Report: FDA Chief Margaret Hamburg to Visit India This Week (PharmAsia-$)
• Group agrees to substitution principles (BioCentury)
• Economic Assessment of FDA's Generic Drug Labeling Rule Claims it Will Raise Costs by $4 Billion Per Year (MGA)
• Drugmakers Tackle Biosimilars Oversight At FTC Forum (Law 360-$) (BioPharma Reporter)
• HHS Wants to Empower Patients by Providing Direct Access to Test Results - Except When It Doesn't (FDA Law Blog)

In Focus: International

• Union Health Minister calls for "Balance" in Clinical Trials Regulations (India Times) (SCRIP-$)
• Could proposed EU Notified Body regulations fizzle out before even taking off? (Clinica-$)
• UK's MHRA updates risk-based site inspection strategies (In Pharma)

US: Pharmaceuticals/Biotechnology

• Report: FDA Chief Margaret Hamburg to Visit India This Week (PharmAsia-$)
• Group agrees to substitution principles (BioCentury)
• Economic Assessment of FDA's Generic Drug Labeling Rule Claims it Will Raise Costs by $4 Billion Per Year (MGA)
• Drugmakers Tackle Biosimilars Oversight At FTC Forum (Law 360-$) (BioPharma Reporter)
• Top Analytical Method Problems in INDs and BLAs Include Not Enough Detail for FDA Replication and Inadequate Suitability Control (IPQ-$)
• OPDP Enforcement Letters Target Common Issues in Last Half of 2013 (CHC)
• Patient advocates urge Congress for fast action on muscular dystrophy drug (BioFlash)
• Doctors Group Sues FDA, Saying Drug Does More Harm Than Good (Courthouse News)
• Consumer Group Challenges FDA on Vascepa Anchor SPA Decision (Press)

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

• FDA Grants Fast Track Designation to Omeros' OMS824 Huntington's Disease Program (Press)
• Ipsen says to seek approval for muscle-spasm drug (Reuters)
• Furiex irritable bowel syndrome drug succeeds in large trials (Reuters)
• FDA Grants Orphan Status to Edison Ataxia Drug (Press)

US: Pharmaceuticals and Biotechnology: General

• Morning Sickness Drug Diclegis Only FDA-Approved Drug on Market. So Why Won't Insurers Cover it? (DrugWonks)
• Over-The-Counter Drugs: A Prescription For Confusion (C-HIT)
• Va. lawmakers expected to set electric chair as backup when lethal injection unavailable (Washinton Post)
  Medicate responsibly, urges maker of Tylenol (MM&M)

US: Medical Devices

• HHS Wants to Empower Patients by Providing Direct Access to Test Results - Except When It Doesn't (FDA Law Blog)
• Direct-to-Consumer Testing's Constitutional Appeal: As supporters cite free speech, and critics the risk of harm, silence may signal a solution (GEN)
• When do you need a registry? AdvaMed's new threshold questions (Mass Device) (Gray Sheet-$) (AdvaMed)
• How Did Medical Device Security Become a Problem? (MDDI)

US: Assorted And Government

• Quantifying the FDA's rulemaking delays highlights the need for transparency (Press) (Health Affairs)

Upcoming Meetings And Events

• 4-5 February 2014: FTC Biosimilars Workshop (FTC)
• 5 February 2014: FDA Science Board Meeting (FDA)
• 10 February 2014: E&C Committee on Drug Shortage Problem (E&C)
• 19 February 2014: FDA OAGS Small Business Outreach Vendor Fair (FDA)
• Other Upcoming FDA Advisory Committee Meetings And Topics (FDA)

Europe

• Could proposed EU Notified Body regulations fizzle out before even taking off? (Clinica-$)
• UK's MHRA updates risk-based site inspection strategies (In Pharma)

India

• Union Health Minister calls for "Balance" in Clinical Trials Regulations (India Times) (SCRIP-$)
• Gilead, local generic players in talks to bring hepatitis C drug into India   (Hindu Business Line)

Other International

• MSF Director: 'We are losing the battle' for cheap drugs in developing world (EurActiv)

Regulatory Reconnaissance #250 - 5 February 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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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].