Regulatory Reconnaissance: FDA Tests Blood Pressure Pills, Citing Concerns About Generics (7 May 2014)

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In Focus: US

• Thousands of Complaints on Blood-Pressure Drugs Spur FDA Testing (Bloomberg)
• FDA's Woodcock Prioritizes Trial Networks As Drug Development Solution (Pink Sheet-$) (SCRIP-$)
• FDA Ramps Up in Preparation of Start of 2015 PDUFA Period (FDA)
• Petition: FDA Should Remove Ranbaxy's Roadblock to Generic Competition on Several Drugs (FDA Law Blog)
• Compounder Reaches $100M Deal In Meningitis Outbreak MDL (Law 360-$) (WSJ-$) (AP) (NBC) (Press) (SCRIP-$)
• FDA morcellator warning spurs lawsuit against J&J (Mass Device) (Law 360-$)
• FDA: Foreign medtech firms receive excess manufacturing violations (Mass Device)

In Focus: International

• Library changes seen as risk to Health Canada's credibility (CBC)
• Germany's BfArM seeking new head (SCRIP-$)
• Germany's IQWiG verdict for Sovaldi sets scene for tough pricing negotiations (SCRIP-$)
• India moves to restore its reputation after FDA sanctions several generic drug suppliers (Reuters) (Fierce) (SCRIP-$) (PharmaBiz) (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

• Thousands of Complaints on Blood-Pressure Drugs Spur FDA Testing (Bloomberg)
• FDA's Woodcock Prioritizes Trial Networks As Drug Development Solution (Pink Sheet-$) (SCRIP-$)
• FDA Ramps Up in Preparation of Start of 2015 PDUFA Period (FDA)
• FDA Releases 2012 CDER Ombudsman Report (FDA)
• Citizen Petition Issues a Clarion Call to FDA to Remove Ranbaxy's Roadblock to Generic Competition on Several Drugs (FDA Law Blog)
• FDA Touts Breakthrough Approval of Zykadia (FDA)
• FDA Science Board to Again Discuss Sourcing of Heparin (FDA)

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

• Medivir: a Supplemental New Drug Application Has Been Submitted to the U.S. FDA for Simeprevir in Combination with Sofosbuvir (Press)
• Janssen Submits Supplemental New Drug Application to FDA for OLYSIOT (Simeprevir) (Press)
• Pacira Pharmaceuticals, Inc. Announces sNDA Submission for EXPAREL Nerve Block Indication (Press)
• FDA, CoLucid Agree on Migraine Drug SPA (DD&D)
• Merck: We'll seek FDA approval for delayed osteoporosis, post-anesthesia drugs this year (MedCity News)
• The Feuerstein-Ratain Rule Update: Still Perfect Predicting Small-Cap Cancer Drug Failure (The Street)

US: Pharmaceuticals and Biotechnology: General

• Compounder Reaches $100M Deal In Meningitis Outbreak MDL (Law 360-$) (WSJ-$) (AP) (NBC) (Press) (SCRIP-$)
• Drug Take-Back Bill Amended To Make Requirements Voluntary (CA Healthline)
• Clinton Foundation working to reduce cost of anti-overdose drug (The Hill)
• Breakthrough Cancer Drugs Inflate Treatment Costs (AP)
• Prescription-Drug Databases Go Behind Privacy Wall (WSJ-$)
• Payers already fretting about the next pharm-apocalypse: Pricey PCSK9 cholesterol meds (Fierce) (Pink Sheet-$)
• Researchers Float Using IND Regulations to Prevent Drug Use in Death Penalty (Think Progress)

US: Medical Devices

• FDA morcellator warning spurs lawsuit against J&J (Mass Device) (Law 360-$)
• FDA: Foreign medtech firms receive excess manufacturing violations (Mass Device)
• Alere recalls blood clot test strips after reports of 9 serious adverse events (Reuters) (FDA)
• FDA Warns Cook On Marketing Unapproved Dilator Sheaths (Gray Sheet-$)
• Propeller Health Grabs 510(k) Clearance For Newest Iteration (Gray Sheet-$) (MobiHealthNews)
• Biosensors lands FDA OK to launch U.S. trial of drug-eluting stent (Mass Device)

US: Assorted And Government

• OMB Releases Budget Guidance to Federal Agencies (OMB-PDF)
• White House opposes House bill on R&D tax credit (BioCentury)

Europe

• Germany's BfArM seeking new head (SCRIP-$)
• Germany's IQWiG verdict for Sovaldi sets scene for tough pricing negotiations (SCRIP-$)

India

• India moves to restore its reputation after FDA sanctions several generic drug suppliers (Reuters) (Fierce) (SCRIP-$) (PharmaBiz) (PharmAsia-$)

Japan & China

• Viagra Faces Stiff Competition In China (PharmAsia-$)

Other International

• Library changes seen as risk to Health Canada's credibility (CBC)

General Regulatory And Interesting Articles

• Is This How We'll Cure Cancer? (Forbes)
• Eight Opportunities for QbD (Pharma Manufacturing)
• Harvard's bone marrow-on-a-chip could replace animal drug testing (Fierce)

Regulatory Reconnaissance #313 - 7 May 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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