Regulatory Recon: FDA Sued by Groups Seeking Access to Clinical Trials Data (30 June 2015)

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

A quick note from your editor: After five wonderful years working at RAPS, my last day will be on 2 July 2015. More on that here. You have my sincerest thanks for your readership over the years.

Regulatory Recon will live on under a new editor.

In Focus: US

• FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data (Pharmalot) (Law 360-$) (Reuters)
• Is the FDA Too Tough on Medical Device Makers? (Wharton) (Fierce)
• Naloxone – FDA hosts meeting to discuss expanded use of overdose medicine (FDA)
• Do Drug Ads Tell Consumers Enough About Benefits and Side Effects? (J. Health Comm.-$)
• In-Depth With CDRH Compliance Chief Jan Welch Trumpets (Gray Sheet-$)
• ​​How patient preference data make patient engagement real (BioCentury-$)
• FDA: We Expect to Issue Biosimilar Interchangeability Guidance in 2015 (FDA)
• Novartis to test new pricing model with heart failure drug (Reuters)

In Focus: International

• An EMA Update on the publication of clinical data (EMA)
• 'Grexit' could spur drug shortages in Europe, industry fears (PharmaTimes)
• Medicines and Healthcare products Regulatory Agency business plan published (MHRA) (MHRA)
• Should the EU Have a Uniform Approach to Drug Pricing? (Politico)
• EC Authorizes Use of BMS's Opdivo (EC)
• ICH clarifies Q7 guidance on API GMP manufacturing (In-Pharma)
• Lilly is Fined by Brazil for 'Sham' Litigation Over a Cancer Drug Patent (Pharmalot)

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US: Pharmaceuticals and Biotechnology

• FDA is Sued by Advocacy Groups That Want Gilead Hepatitis C Trial Data (Pharmalot) (Law 360-$) (Reuters)
• Naloxone – FDA hosts meeting to discuss expanded use of overdose medicine (FDA)
• Do Prescription Drug Ads Tell Consumers Enough About Benefits and Side Effects? Results From the Health Information National Trends Survey, Fourth Administration (J. Health Comm.-$)
• How the Critical Path Initiative Addresses CDER's Regulatory Science Needs (TIRS-$)
• Communicating Benefit and Risk Information in Direct-to-Consumer Print Advertisements (TIRS-$)
• How patient preference data make patient engagement real (BioCentury-$)
• FDA: We Expect to Issue Biosimilar Interchangeability Guidance in 2015 (FDA)
• A Method of Addressing Proprietary Name Similarity for US Prescription Drugs (TIRS-$)
• Vertex Expected to Receive FDA Approval for New CF Drug Later This Week (The Street)
• A Descriptive Evaluation of Prescriber Perceptions and Experience With Risk Evaluation and Mitigation Strategy (REMS) Programs in an Integrated Health Care System (TIRS-$)
• A "Too Old" OTC Product Does Not A Class Action Make (D&D Law)
• India's Dr. Reddy's recalls 10 lots of two drugs that failed specifications (Fierce)

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

• Intercept seeks US accelerated obeticholic acid OK; MAA accepted (SCRIP-$) (BioCentury)
• Telesta Therapeutics Submits Biologics License Application (BLA) to FDA  (Press)
• Roche heralds PhIII successes for MS, but some tough rivals lie in wait (Fierce) (PMLive) (Press)
• Merck plans expanded filing for Emend this year (PMLive)
• Genentech's ocrelizumab Significantly Reduced Both Relapses and Disability Progression versus interferon beta-1a (Rebif) in Two Phase III Studies in Multiple Sclerosis (Press)
• Boehringer diabetes drug misses endpoint (PharmaTimes)

US: Pharmaceuticals and Biotechnology: General

• ​​Novartis to test new pricing model with heart failure drug (Reuters)
• How new drugs helping millions of Americans live longer are also making them go broke (WaPo)
• California Senate Passes Tough Vaccine Law (NBC) (Reuters)
• Supreme Court Allows Use of Execution Drug (NYTimes) (SCOTUS)
• Amgen files IPRs against Humira patents (BioCentury)
• State restrictions for hepatitis C drug may go too far (Reuters)

US: Medical Devices

• Is the FDA Too Tough on Medical Device Makers? (Wharton) (Fierce)
• In-Depth With CDRH Compliance Chief: Jan Welch Trumpets 'Case For Quality,' Urges Feedback From Manufacturers (Gray Sheet-$)
• Emergency Use Authorizations: In Vitro Diagnostic Device for Detection of Enterovirus D68 (FDA)
• Olympus faces new suit from UCLA superbug patient over duodenoscope device (Fierce)
• Mitigating Risks of Materials Failures in Medical Devices (MDDI)
• 3D Printing and Legal Liability (D&D Law)
• Teleflex Incorporated Announces Worldwide Voluntary Recall of Hudson RCI LIFESAVER Neonate Manual Resuscitator (Press)
• Centinel Spine is Granted the First Cervical Multilevel Indication for Its STALIF C Integrated Interbody Device (Press)

US: Dietary Supplements

• A lack of leadership at FDA, the Dietary Supplement Labeling Act of 2015, and a 'tenderized' industry: Mister's State of the Union (NI-USA)
• FDA cites 47 separate disease claims in warning letter to Wyoming firm (NI-USA)

US: Assorted And Government

• FasterCures Launches Science of Patient Input Program (FasterCures)

Upcoming Meetings and Events

• RAPS' FDA Advisory Committee Meeting Tracker

Europe

• An EMA Update on the publication of clinical data (EMA)
• 'Grexit' could spur drug shortages in Europe, industry fears (PharmaTimes)
• Medicines and Healthcare products Regulatory Agency business plan published (MHRA) (MHRA)
• Should the EU Have a Uniform Approach to Drug Pricing? (Politico)
• EC Authorizes Use of BMS's Opdivo (Nivolumab)
• Opdivo approved via UK's early drug access scheme (PMLive) (Pharmafile)
• EC Authorizes Use of Daiichi Sankyo's Lixiana (Edoxaban)
• New clinical evaluation and vigilance transparency initiatives ahead of EU Regulations: helpful or scary? (Clinica-$)
• Learning to Live With AMNOG (McKinsey)
• Monitoring and Evaluating the Effect of Regulatory Action in the EU (TIRS-$)
• PIP flashback? Recent EU recall underlines need for closer monitoring of suppliers (Clinica-$)
• European Commission approves Orfadin oral suspension (PBR)
• EU stands by crackdown on drug spending in Ireland (Fierce)
• An Analysis of the Fixed-Dose Combinations Authorized by the European Union, 2009-2014 (TIRS-$)
• Reporting requirements of Individual Case Safety Reports (ICSRs) applicable to marketing authorisation holders during the interim period (EMA)
• SinuSys Corp. Receives CE Mark for Vent-Os Sinus Dilation System for Treatment of Frontal and Sphenoid Sinusitis (Press)

India

• Expert committee on track and trace system meets stakeholders in Mumbai (PharmaBiz)
• State drug regulators take action against not-of-standard quality medical devices under D&C Act (PharmaBiz)
• Set up 'office of drugs safety' in DC depts to handle drugs safety issues & post-marketing surveillance: Dr Satheesh Kumar (PharmaBiz)

Japan

• Bayer Submits an Application for Market Authorization of Recombinant Factor VIII Product as a Treatment of Hemophilia A in Japan (Press)

Canada

• A Primer on Canadian Medical Device Regulations (MDDI)
• Health Canada asks importers to quarantine Polydrug APIs over data concerns (In-Pharma)

Clinical Trials

• How Google X thinks a wearable diagnostic device can improve clinical trials (BioCentury-$)

Other International

• ICH clarifies Q7 guidance on API GMP manufacturing (In-Pharma)
• Lilly is Fined by Brazil for 'Sham' Litigation Over a Cancer Drug Patent (Pharmalot)
• Hong Kong regulators issue list of recognized standards for medical devices (MassDevice)
• Industry working group to 'test ideas' for New Zealand's drug/device regulations (Clinica-$)

General Regulatory And Interesting Articles

• New role for Twitter: Early warning system for bad drug interactions (Press)

Regulatory Reconnaissance #586 – 30 June 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.

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