Regulatory Recon: Get Ready for Cybersecurity-Based Device Rejections (6 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 cybersecurity rejections are on the way (Mass Device)
• Neuralstem to offer experimental therapy outside trial. Will FDA Intervene? (BioCentury)
• Wanted: a watchdog for the mobile medical app explosion (Reuters)
• FDA AdComm to Discuss Power Morcellator Devices at July Meeting (FDA)
• USP starts field trials of FDA fake drug screening device (Securing Industry)
• FDA Wants to Test the Safety of PEG Products Used in Pediatric Populations (FDA)

In Focus: International

• Italian fraud squad raids drug agency in Roche-Novartis probe (Fierce)
• AllTrials to EMA: New proposals will make scrutiny of data almost impossible (AllTrials)
• Overhaul complete for EU clinical trials (Nature)
• Public consultation opens on EMA’s draft guide on monitoring of medical literature (EMA) (EMA)
• After Regulatory Lapses, India's Drug Makers Move Toward Automation (WSJ-$)
• Five Arab-League Nations To Kick Off Drug-Safety Guidelines Next Year (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

• Novartis Antibiotic Web Page Draws Scrutiny (Pharmalot)
• DMFs in the Spotlight at the GPhA/FDA CMC Workshop (Lachman)
• FTC Tells the NAD: “Thanks for Nothing” (FDA Law Blog)
• Genzyme Cleared of Wrongdoing in Regulatory Lawsuit (Court Decision)
• FDA Wants to Test the Safety of PEG Products Used in Pediatric Populations (FDA)
• Woodcock: Drug development in serious diseases: the new "breakthrough therapy" designation (PubMed)
• FDA Drug Shortage Strategy: Heparin Is Test Case For Developing Alternate Sources (Pink Sheet-$)
• Massachusetts Biosimilar Interchangeability Bill Introduced (Massachusetts)
• Opinion: FDA's recent IRB guidance more style than substance (The Hill)
• Veterinary Group Paying Close Attention to Compounding (Veterinary Practice News)
• Modeling and simulation of biopharmaceutical performance (PubMed)
• Improving the assessment of heart toxicity for all new drugs through translational regulatory science (Nature)
• Exploring the FDA adverse event reporting system to generate hypotheses for monitoring of disease characteristics (PubMed)
• Statistical consideration and challenges in bridging study of personalized medicine (PubMed)
• Physiologically based pharmacokinetic modeling: from regulatory science to regulatory policy (PubMed)
• The FDA's risk/benefit calculus in the approvals of Qsymia and Belviq: treating an obesity epidemic while avoiding another fen-phen (PubMed)
• ASCO recommends new incentives for pediatric trials (BioCentury)
• FDA Starting Work on DILI Testing (FDA)
• NJ Bill Urges FDA to Reconsider Approval of Zohydro (NJ)
• Merck Accused Of Advertising Bogus Sunscreen SPF Claims (Law 360-$)
• Strides Arcolab gets FDA approval to market skin disease drug in US (India Times)
• USFDA inspects Divis Laboratories' facility in India (PTI)

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

• Neuralstem to offer experimental therapy outside trial (BioCentury)
• FDA gives orphan drug status to Momenta’s investigational pancreatic cancer treatment (MedCityNews)
• US FDA grants Fast Track designation for GW Pharma’s Epidiolex in Dravet syndrome (Pharma Letter-$)
• US: Pharmaceuticals and Biotechnology: General
• USP starts field trials of FDA fake drug screening device (Securing Industry)
• The Truth about Fake Medicines (Lillypad)
• Sunshine… Or Clouds? Drug Makers Grapple With Transparency Law (Pharmalot)
• Study: sales rep limits reduce off-label prescriptions (MedCity News)
• US patient assistance programmes - a critique (PharmaPhorum)

US: Medical Devices

• FDA cybersecurity rejections are on the way (Mass Device)
• Wanted: a watchdog for the mobile medical app explosion (Reuters)
• FDA AdComm to Discuss Power Morcellator Devices at July Meeting (FDA)
• FDA panel to examine corneal implant for aging eyes (Fierce)
• Shuren: The FDA's role in the development of medical mobile applications (PubMed)
• $100M NuvaRing Settlement Finalized (AP)
• FDA concerns have been resolved, Cardiac Assist says (BizJournal)
• No more secrecy in medtech pricing, says Sen. King (Mass Device)

US: Assorted And Government

• Animal-rights group calls for MIT fine after death of rabbit in lab (Reuters)
• S.2407 -- 21st Century Global Health Technology Act (Senate)

Europe

• Italian fraud squad raids drug agency in Roche-Novartis probe (Fierce)
• AllTrials to EMA: New proposals will make scrutiny of data almost impossible (AllTrials)
• Overhaul complete for EU clinical trials (Nature)
• Public consultation opens on EMA’s draft guide on monitoring of medical literature (EMA) (EMA)
• Pradaxa gains EU approval for treatment and prevention of recurrence of deep vein thrombosis and pulmonary embolism (Press) (Pharmafile)
• EMA accepts resubmitted Raxone MAA (BioCentury)
• Official medicines control laboratories: evolution of its role in Europe in surveillance and control of medicines on the market (EDQM)
• German health insurers implore G-BA to squeeze pharma more (SCRIP-$)
• Industry calls for EU decision-makers to grasp diverse medtech needs (Clinica-$)

India

• India's Drug Makers Move Toward Automation (WSJ-$)
• India Drug Makers Ordered To Supply Drug-Cost Data Or Face Penalties (PharmAsia-$)

Other International

• Five Arab-League Nations To Kick Off Drug-Safety Guidelines Next Year (PharmAsia-$)
• Ensuring medical device effectiveness and safety: a cross--national comparison of approaches to regulation (PubMed)
• Is Aus medtech industry being fleeced by high regulatory fees? (Clinica-$)

General Regulatory And Interesting Articles

• Toxicokinetic Tips (Cato)
• New Coating May Finally Help Make Artificial Joints Last a Lifetime (MedGadget)

Regulatory Reconnaissance #333 – 6 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.

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