Regulatory Recon: White House Raises Objections to Funding and Exclusivity Provisions in Cures Act (9 July 2015)
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
- White House has Reservations on Funding and Exclusivity Provisions in 21st Century Cures Act (BioCentury) (SCRIP-$) (White House)
- FDA Goes After Drugmakers for Unpaid GDUFA Fees (FiercePharmaManufacturing) (Economic Times) (FDA)
- FDA Looking at Electronic Health Records in Clinical Trial Data Capture (FierceEMR) (Federal Register)
- White House Issues Privacy Guidelines for Precision Medicine (SCRIP-$) (BioCentury) (FierceHealthIT) (White House)
- ANDA Approvals Strong Again; Has FDA Turned The Corner? (Pink Sheet-$)
- Janet Woodcock Defends FDA's Off-Label Policy (RPM Report-$)
- FDA Plans Acute Stroke Device Workshop; Guidance Could Follow (Gray Sheet-$)
- A Spotlight on Sunscreen Regulation (NEJM) (Correspondence by FDA)
In Focus: International
- Greek health system nears collapse (EurActiv)
- Novartis Counting on International Approvals in $5bn Entresto Sales Prediction (Fortune) (Press)
- EMA: Summary of Workshop on Therapeutic use of Bacteriophages (EMA)
- EMA: Statistics on Certificates of Medicinal Products 2014 (EMA)
- EMA Releases Draft Guideline on the Manufacture of Finished Dosage Form (EMA)
- Genmab, Novartis leukemia drug Arzerra filed for European approval (Reuters)
- Sanofi advances a one-shot malaria program as drug resistance spreads (FierceBiotech)
US: Pharmaceuticals and Biotechnology
- White House Issues Privacy Guidelines for Precision Medicine (SCRIP-$) (BioCentury) (FierceHealthIT) (White House)
- White House has Reservations Toward Funding and Exclusivity Provisions in 21st Century Cures Act (BioCentury) (SCRIP-$) (White House)
- ANDA Approvals Strong Again; Has FDA Turned The Corner? (Pink Sheet-$)
- Janet Woodcock Defends FDA's Off-Label Policy (RPM Report-$)
US: Pharmaceuticals and Biotechnology: Clinical Study Results, Filings and Designations
- FDA Approves First COPD Biomarker (Press)
- Sanofi, Regeneron see Strong Results in Japanese Phase III Praluent Trial (Reuters)
- Protein Sciences' 2015/16 Flublok Vaccine Formulation Gets FDA Approval (Press)
- Gene therapy for deafness moves a few steps closer (Reuters)
US: Pharmaceuticals and Biotechnology: General
- FDA Goes After Drugmakers for Unpaid GDUFA Fees (FiercePharmaManufacturing) (Economic Times) (FDA)
- FDA Looking at Electronic Health Records in Clinical Trial Data Capture (FierceEMR) (Federal Register)
- A Spotlight on Sunscreen Regulation (NEJM) (Correspondence by FDA)
- Got an idea for an FDA drug study? Send an email (FiercePharmaMarketing)
US: Medical Devices
- FDA Plans Acute Stroke Device Workshop; Guidance Could Follow (Gray Sheet-$)
- Medical Devices Used To Understand Effects On Astronauts' Brains (Gray Sheet-$)
US: Assorted and Government
- 21st Century Cures Act Set for Friday House Floor Vote (FDANews-$)
- Senate Republicans: We Have The Votes To Repeal Medical Device Tax (MedDeviceOnline)
- CA Court Declines to Rehear Cipro Pay-For-Delay Case (Law360-$)
Upcoming Meetings and Events
Europe
- Greek health system nears collapse (EurActiv)
- Novartis Counting on International Approvals in $5bn Entresto Sales Prediction (Fortune) (Press)
- EMA: Summary of Workshop on Therapeutic use of Bacteriophages (EMA)
- EMA: Statistics on Certificates of Medicinal Products 2014 (EMA)
- EMA Releases Draft Guideline on the Manufacture of Finished Dosage Form (EMA)
- Genmab, Novartis leukemia drug Arzerra filed for European approval (Reuters)
- Sanofi advances a one-shot malaria program as drug resistance spreads (FierceBiotech)
- Phase 2b Findings Support Guselkumab in Treatment of Plaque Psoriasis (EuropeanPharmaceuticalReview) (NEJM)
India
- Health Ministry Initiates Sampling on Spurious, NSQ Drugs at 12 Notified Ports (PharmaBiz)
China
- Emerging Markets Regulatory Tracker: China Revises GSP (PharmAsiaNews)
Australia
- TGA Warns of Cardiovascular Risk for Patients Taking Coralan (TGA)
- TGA Finds Undeclared Viagra in Illegal Supplement (TGA)
Other International
- The Expansion of Corruption Enforcement in the Global Market (Pharmaceutical Compliance Monitor)
- Lupin says no Revenue hit From ANVISA action (SCRIP-$)
- General Regulatory and Interesting Articles
- Genomic Data Growing Faster Than Twitter and YouTube (IEEE Spectrum)
- Promising Cholera Vaccine Could Curb Future Outbreaks (NYTimes) (Lancet)
- Study Finds Small Increased Risk of Birth Defects with Prozac, Paxil Use (WSJ) (NPR)
- Egg Shortage Hits Healthcare Industry (Modern Healthcare)
- Regulatory Reconnaissance #592 – 9 July 2015
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 @Michael_Mezher or send him an email at [email protected].
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