Regulatory Recon: What FDA and Apple Talked About Earlier this Year (10 June 2014)

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing. Read anything we might be interested in sharing? Let us know: [email protected].

In Focus: US

• FDA details high-level meeting with Apple: “Moral obligation to do more” with health, innovative sensors (9to5 Mac)
• FDA reviewers question CV risk with opioid-induced constipation pills (BioCentury) (Fierce) (SCRIP-$) (Pink Sheet-$)
• Legal experts question FDA guidance on new risk information (BioCentury)
• Massachusetts sued by Zogenix over restrictions on painkiller Zohydro (AP) (Herald)
• Orexigen: 'Goldilocks' Obesity Pill Awaits FDA Approval Decision Wednesday (The Street) (Forbes) (CNBC)
• Jury's out whether recent data shows improvement in NDI picture (NI-USA)

In Focus: International

• China proposes bringing police, media to unannounced drug inspections (Clinica-$)
• InterMune has dropped its case against the EMA (AllTrials) (Pharmafile)
• Germany hosts European pilot scheme to fight drug counterfeiting (PJO)
• AllTrials Takes EMA Data Fight to the EC's Paola Testori Coggi (AllTrials)
• Clinical Research Comes to a Grinding Halt in India (Business-Standard)
• ASEAN’s soon-to-be device rules will have similar impact to EU’s MDD (Clinica-$)

US: Pharmaceuticals and Biotechnology

• FDA reviewers question CV risk with opioid-induced constipation pills (BioCentury) (Fierce) (SCRIP-$) (Pink Sheet-$)
• Legal experts question FDA guidance on new risk information (BioCentury)
• Massachusetts sued by Zogenix over restrictions on painkiller Zohydro (AP) (Herald)
• Abbott, AbbVie get to defend testosterone lawsuits on their own turf (Fierce) (IBJ) (Crain's)
• Orexigen: 'Goldilocks' Obesity Pill Awaits FDA Approval Decision Wednesday (The Street) (Forbes) (CNBC)
• Opioid Postmarket Study Reveals Drug Monitoring Program Weaknesses (IHP-$)
• Progress of FDA’s Compliance/Enforcement Data Transparency Initiative Will Be Spurred by Refined Road Map from Working Groups (IPQ-$)
• After REMS: An Interview With Amgen’s Paul Seligman (RPM Report-$)
• 2nd Circ. Affirms Dismissal Of Adderall Pay-For-Delay Suit (Law 360-$)

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

• Achillion soars (again) as FDA lifts a hold and hep C returns to the spotlight (Fierce) (Reuters)
• Priority Review for Imbruvica for CLL, SLL (BioCentury)
• EffRx Receives U.S. Orphan Drug Designation for EX404 for Treatment of Pediatric Polycystic Ovary Syndrome (Press)
• NPS Pharma Reports Change in Tentative Date of FDA Advisory Committee Review of Natpara BLA to September 12 - PDUFA Date of October 24 Remains Unchanged (Press)

US: Pharmaceuticals and Biotechnology: General

• Top opioid prescribers not pain specialists (MM&M)
• Top 5% of opioid prescribers write 40% of US narcotic prescriptions (Pharma Letter-$)
• Here’s why specialty pharmaceuticals need value-based insurance design (Health Journalism)

US: Medical Devices

• FDA details high-level meeting with Apple: “Moral obligation to do more” with health, innovative sensors (9to5 Mac)
• FDA Investigators Offer 8 Inspectional Insight (Silver Sheet-$)
• AcuFocus's Kamra Inlay wins a narrow nod from FDA panel (Mass Device) (Fierce)
• Anulex Escapes Off-Label Suture Suit (Law 360-$)
• FDA clears new model of sleep apnea diagnostic device (Fierce) (Press)
• Auxogyn Receives FDA Clearance for Its Eeva System (Press)

US: Dietary Supplements

• Jury's out whether recent data shows improvement in NDI picture (NI-USA)
• FDA Files New Ingredient Notification for Omega-3 Oil (NPI)
• US: Assorted And Government
• Sebelius hands reins to successor (The Hill)
• Dr. Benson Silverman, a neonatologist who led the FDA's infant formula initiative, died 7 June 2014

Europe

• InterMune has dropped its case against the EMA (AllTrials) (Pharmafile)
• Germany hosts European pilot scheme to fight drug counterfeiting (PJO)
• AllTrials Takes EMA Data Fight to the EC's Paola Testori Coggi (AllTrials)
• MEP urges EMA to postpone adoption of data disclosure policy (SCRIP-$)
• NICE under fire over guidance for MS drugs Fampyra, Sativex (PharmaTimes)
• India
• Clinical Research Comes to a Grinding Halt in India (Business-Standard)

Japan & China

• China proposes bringing police, media to unannounced drug inspections (Clinica-$)
• Light at the end of the tunnel for China supplement importers (NI-USA)

Canada

• Health Canada pulls Winnipeg drug wholesaler’s licence, citing GMPs (Global News) (CBC)

Other International

• ASEAN’s soon-to-be device rules will have similar impact to EU’s MDD (Clinica-$)
• IVD reagents to be regulated as medical devices in South Korea (Mass Device)
• Brazil Drug Makers Struggle To Meet 2016 Serialization Deadline (PharmAsia-$)

General Regulatory And Interesting Articles

• Pfizer: How Facebook can ‘unblind’ a clinical trial (Outsourcing Pharma)
• Adaptive Trial Design: Prepping for Adoption (PharmExec)
• Could Antibiotics Resistance be Slowed by a Single Injection? (In-Pharma)
• French docs implant world's 1st 3D printed spinal cage (Mass Device)

Regulatory Reconnaissance #335 – 10 June 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.

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 [email protected].

A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.