Regulatory Recon: FDA Gives Industry More Time to Comment on Quality Metrics (26 August 2015)

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In Focus: US

• FDA Extends Quality Metrics Comment Period Through 27 November 2015 (Federal Register) (Focus)
• FDA, From a Distance (FDA Voice)   
• FDA Releases Primer on Rare Disease Drug Development, Discusses Utility of Natural History Studies (FDA Law Blog) (Focus)
• Nine Explanations For Why The FDA Is Approving Almost Every New Drug Application (Forbes)
• FDA Posts Biological Products Naming Rule with OMB (FDANews-$)
• Is the FDA Too Conservative or Too Aggressive? (MarginalRevolution)
• FDA's Focus On Drug Appearance May Cause Ugly Problems (Law360-$)
• Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting (FDA)
• FDA task force: Use network of registries to track med devices (FierceMedicalDevices) (Gray Sheet-$)
• FDA Warning Wire: Device Makers Feel Inspection Heat (Law360-$)

In Focus: International

• EU's IMI Plans Projects On 'Big Data' In Health Outcomes (SCRIP-$)
• French Authority (ANSM) published statement of non-compliance related to mold contaminations (ECA)
• CFDA Said Considering Shortening Oncology Drug INDs To 60 Days (PharmAsiaNews)
• China Device Reforms Aplenty: Multiple Regulatory Changes Are Imminent (Gray Sheet-$)
• Chugai Pharma makes regulatory filing for CellCept (PharmaLetter-$)
• Brazil’s pharmaceutical market to continue to prosper (EuropeanPharmaceuticalReview)
• Guided Therapeutics presses on in Costa Rica despite FDA setbacks (MassDevice)

US: Pharmaceuticals and Biotechnology

• FDA Extends Quality Metrics Comment Period Through 27 November 2015 (Federal Register) (Focus)
• FDA, From a Distance (FDA Voice)   
• FDA Releases Primer on Rare Disease Drug Development, Discusses Utility of Natural History Studies (FDA Law Blog) (Focus)
• Nine Explanations For Why The FDA Is Approving Almost Every New Drug Application (Forbes)
• Infographic: FDA Inspections By The Numbers (Master Control)
• 50 Shades Of Regulatory Gray: More Flexible FDA?  (SCRIP-$)
• FDA Posts Biological Products Naming Rule with OMB (FDANews-$)
• OIG Issues Advisory Opinion Regarding Pharmaceutical Manufacturers’ Program to Provide Free Limited Drugs to Beneficiaries When Insurance Coverage Is Delayed (King & Spalding)
• Greater transparency is resulting in fewer ‘positive’ findings in clinical trials (AHCJ)
• Scientists report major step in development of Universal Flu Vaccine (Washington Post)
• Scientists’ Structural Discoveries Could Aid in Better Drug Design (DD&D)

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

• Sarepta Wins Priority Review For Duchenne Drug Eteplirsen (SCRIP-$)
• FDA Grants Priority Review to Sarepta Drug Candidate (WSJ-$)
• Amgen files for etelcalcetide approval in USA (PharmaLetter)
• US Breakthrough designation for Exelixis’ cabozantinib for RCC (PharmaLetter)
• The Impact of a One-Dose versus Two-Dose Oral Cholera Vaccine Regimen in Outbreak Settings: A Modeling Study (PLOS Medicine)
• Scripps and Janssen make major advance on more effective, long-lasting flu vaccine (PharmaLetter-$)
• Beta blockers may prolong survival in ovarian cancer patients (Pharmaceutical Journal)
• US filing for Amgen's secondary hyperparathyroidism drug (PharmaTimes)
• FDA grants Tocagen’s glioblastoma drug orphan status (PMLive)

US: Pharmaceuticals and Biotechnology: General

• Is the FDA Too Conservative or Too Aggressive? (MarginalRevolution)
• FDA's Focus On Drug Appearance May Cause Ugly Problems (Law360-$)
• Examining the Amarin VASCEPA Saga: Off-Label Promotion (The 505(b)(2) Blog)

US: Medical Devices

• Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting (FDA)
• FDA task force: Use network of registries to track med devices (FierceMedicalDevices) (Gray Sheet-$)
• FDA Warning Wire: Device Makers Feel Inspection Heat (Law360-$)
• Dexcom receives FDA 510(k) clearance for Bluetooth-enabled CGM G5 (MobiHealthNews)
• SmartPill Successfully Measures pH Inside Gut (medGadget)
• Dental device promises pain-free tooth repair (Reuters)
• HealthMyne Announces FDA Clearance of Imaging Informatics Platform (Press)
• Edap revives Ablatherm HIFU FDA approval bid (MassDevice)            
• FDA approves first self-contained, mobile continuous blood glucose monitor from Dexcom (FierceMedicalDevices)
• Are Your Medical Devices HIPAA Compliant? (MDDI)
• Medeon Biodesign Receives FDA 510(k) Clearance for ClickClean Laparoscope Lens Cleaning Device (MedDeviceOnline)

US: Assorted and Government

• White House Is Pressed to Help Widen Access to Hepatitis C Drugs via Medicaid (NYTimes)
• US Patent Board To Review Mylan's Copaxone Challenge (SCRIP-$)
• Patent Challenges Via IPR Still Pretty Scary, Even After Acorda's Win (Pink Sheet-$)
• Lilly: U.S. Court Rules in its Favor on Alimta Patent (WSJ-$)
• Bristol-Myers, Sanofi catch a break in Plavix marketing case (FiercePharma)
• Bill Would Ban Synthetic Marijuana in New York City (WSJ)
• As Legal Marijuana Expands, States Struggle With Drugged Driving (KHN)
• In huge victory for generics, court invalidates Takeda's Velcade patent (BioPharmaDive)

Upcoming Meetings and Events              

• RAPS' FDA Advisory Committee Meeting Tracker

Europe

• EU's IMI Plans Projects On 'Big Data' In Health Outcomes (SCRIP-$)
• French Authority (ANSM) published statement of non-compliance related to mold contaminations (ECA)
• Huge variations in cardiovascular death rates across Europe (OnMedica)

India

• NIH experts visit Gujarat FDCA to examine biocompatibility & medical device testing lab proposal (PharmaBiz)
• Health ministry to amend Schedule K of D&C Rules to exempt cos from GMP compliance for export (PharmaBiz)

China

• CFDA Said Considering Shortening Oncology Drug INDs To 60 Days (PharmAsiaNews)
• China Device Reforms Aplenty: Multiple Regulatory Changes Are Imminent (Gray Sheet-$)

Japan

• Chugai Pharma makes regulatory filing for CellCept (PharmaLetter-$)

Ebola Outbreak

• Researchers Study the Persistence of Ebola Virus in Wastewater (ICT)

Other International

• UK govt backs safe pharmacy scheme in Kenya (Securing Industry)
• Brazil’s pharmaceutical market to continue to prosper (EuropeanPharmaceuticalReview)
• Guided Therapeutics presses on in Costa Rica despite FDA setbacks (MassDevice)
• Teva’s phase III rejig leaves some unanswered questions (EP Vantage)

General Health and Other Interesting Articles

• Omega 3 is still good for the brain. But ‘fish oil supplements just don’t cut it.’ (Washington Post)
• Rockefeller team links a promising cancer drug class to memory loss in mice (FierceBiotech)

Regulatory Reconnaissance #626 – 26 August 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].

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