Regulatory Reconnaissance: Can FDA's Regulatory Processes be Improved? (14 April 2014)

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In Focus: US

• Rep. Upton Plans Bipartisan Talks To Improve FDA Drug Approval Process (IHP-$) (SCRIP-$)
• Steve Solomon Becomes Permanent Deputy Associate Commissioner for Regulatory Affairs (BioCentury)
• Hamburg: Focus on Chronic Illness Drugs Needed (MedPage Today)
• Baxter Healthcare's Ontario Manufacturing Facility Put on Import Alert (FDA)
• Canton Labs hit with US FDA Import Alert at Indian API plant (In-Pharma) (FDA)
• FDA Recruitment Hurt By Sequester, Shutdown - Hamburg (Pink Sheet-$)

In Focus: International

• EU Appears Open To Suggestions On Mobile Health Oversight (Gray Sheet-$)
• EU clarifies law on postmarket trials (BioCentury) (EU)
• GlaxoSmithKline faces bribery allegations in Poland (Guardian) (GSK) (PMLive) (Pharmfile) (SCRIP-$) (Bloomberg)
• September 2014 compliance deadline for Indian medical device labeling rules (Mass Device)
• Knowing Regs Key as China Gets Tougher on GMP Inspections (PharmAsia-$)

US: Pharmaceuticals/Biotechnology

• Steve Solomon Becomes Permanent Deputy Associate Commissioner for Regulatory Affairs (BioCentury)
• Rep. Upton Plans Bipartisan Talks To Improve FDA Drug Approval Process (IHP-$)
• Hamburg: Focus on Chronic Illness Drugs Needed (MedPage Today)
• Baxter Healthcare's Ontario Manufacturing Facility Put on Import Alert (FDA)
• Canton Labs hit with US FDA Import Alert at Indian API plant (In-Pharma) (FDA)
• Benefit-Risk Assessments For Me-Too Drugs Encouraged By FDA (Pink Sheet-$)
• Pharmacy Metric Dispensing: Is Compliance Possible Without Mandates? (Pink Sheet-$)
• Zogenix Launches Vigorous Defense of Zohydro (PharmPro)
• U.S. judge set to rule on drug firm's suit against Massachusetts for painkiller ban (Washington Post)
• Breakthrough Therapies: Maintain The Statistical Rigor, Industry Says (Pink Sheet-$)
• FDA Approves Lipiodol Injection For Tumor Imaging (Press)
• FDA Approves Novartis' ALK Inhibitor! Maybe...Really Soon? (The Street)
• FDA Helping Pharma Operationalize Social Media (MediaPost)
• DSCSA: Many Questions, Few Answers (RxTrace)
• CBER Moving Next Week (FDA)
• FDA Extends Market Exclusivity of BioMarin's KUVAN Powder for Oral Solution and Tablets (Press)
• March 2014 Drug Safety Labeling Changes (FDA)

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

• Impax resubmits Rytary NDA (BioCentury) (DD&D)
• BMS Submits NDA for a Fixed-Dose Combination Tablet of Atazanavir Sulfate with Cobicistat for HIV-1 (Press)
• Intercept grabs the spotlight at EASL, builds case for lead drug OCA (Fierce)(Reuters) (SCRIP-$)
• J&J says halting development of Botox rival (Reuters) (Pharma Times)
• AbbVie, Gilead, Janssen dazzle with Hep C data (SCRIP-$)
• AbbVie angles for hep C spotlight as Merck shoulders to the front (Fierce) (DD&D)
• BMS hep C combo good, but is it good enough? (SCRIP-$)
• Ispen Reports PhIII Results for Dysport (Press)
• pSivida Announces September 26, 2014 PDUFA Date for ILUVIEN (Press)

US: Pharmaceuticals and Biotechnology: General

• California Looks to Limit Antibiotics Prescribing (CA)
• CDC continues to recommend Tamiflu, Relenza (BioCentury)
• National Cancer Institute investigating trial outliers to resurrect 'failed' drugs (Fierce) (Bloomberg)
• Ebola Drug Could Be Ready For Human Testing Next Year (NPR)
• Surge in Prescriptions for Opioid Painkillers for Pregnant Women (NYTimes)
• Secret Drugs, Agonizing Deaths (NYTimes)

US: Medical Devices

• Guided Therapeutics gets its day with the FDA (Mass Device)
• Class 1 Recall: Arkon Anesthesia Delivery System (FDA)
• Activist group targets J&J and its transvaginal mesh lawsuits with social media attack (MedCityNews)
• Covidien Announces U.S. Food and Drug Administration 510(k) Clearance for the Kangaroo Feeding Tube with IRIS Technology (Press)

US: Dietary Supplements

• We Worry About Trace Amounts Of BPA While Playing Russian Roulette With Dietary Supplements (Forbes)
• US: Assorted And Government
• FDA Recruitment Hurt By Sequester, Shutdown - Hamburg (Pink Sheet-$)
• DHHS Moves to Restrict Use of its Logo (DHHS)
• Lawyers start mining the Medicare data for clues to fraud (Reuters)
• US Capitol Capsule: Burwell: The 'steady hand' Obama wants at HHS wheel (SCRIP-$)

Europe

• EU Appears Open To Suggestions On Mobile Health Oversight (Gray Sheet-$)
• EU clarifies law on postmarket trials (BioCentury) (EU)
• GlaxoSmithKline faces bribery allegations in Poland (Guardian) (GSK) (PMLive) (Pharmfile) (SCRIP-$) (Bloomberg)
• Hepatitis C Drug Pricing Targeted With HIV-Style Activism In Europe (Pink Sheet-$)
• Seno Imagio Opto-Acoustic Breast Cancer Imaging System Cleared in Europe (MedGadget)
• Registration opens for EMA workshop on the clinical investigation of medicines for the treatment of Alzheimer's disease (EMA)

India

• September 2014 compliance deadline for Indian medical device labeling rules (Mass Device)

Japan & China

• Knowing Regs Key as China Gets Tougher on GMP Inspections (PharmAsia-$)

Other International

• Australia Warns About Medtronic's Paradigm Insulin Pump (TGA)
• Health Canada Inspection Report: High CMDR compliance rates for medical device establishment license holders (Mass Device)

General Regulatory And Interesting Articles

• Idea of New Attention Disorder Spurs Research, and Debate (NYTimes)
• How Morcellators Simplified the Hysterectomy but Posed a Hidden Cancer Risk (WSJ-$)
• How does one pill cost $1,000? (Vox)
• Deadly Bowel Infection Draws Drugmakers Seeking Cures (Bloomberg)

Regulatory Reconnaissance #297 - 14 April 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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