Regulatory Reconnaissance: Quality Issues Sink Eli Lilly's Empagliflozin (6 March 2014)

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In Focus: US

• HHS/FDA Tracking System Keeps an Eye on Those Suing the Agency (FDA Law Blog) (System)
• FDA issues CRL on Eli Lilly's empagliflozin, noting manufacturing deficiencies (Pharma Letter-$) (WSJ-$) (MedPage Today) (Press) (Reuters) (Pink Sheet-$) (Press) (PMLive) (Pharmafile) (Fierce) (Pharma Times) (BioCentury) (Fierce) (SCRIP-$) (Law 360-$) (Bloomberg)
• Obama looks to shorten biologics exclusivity (BioCentury)
• CDER Advisory Panel Vacancies Remain High As Overall FDA Rates Improve (Pink Sheet-$)
• When Does an App Become a Medical Device? (MDDI)
• US fears for patents on next-generation drugs in India (Reuters)

In Focus: International

• EU Parliament may forge ahead on medtech regulations vote without Council (Clinica-$)
• Flies Found By FDA Threaten Indian Town Built on Generics (Bloomberg)
• India defends regulatory system against 'direct assault' (SCRIP-$)
• Novartis may face tough action over 'fake' documents in India (SCRIP-$)

US: Pharmaceuticals/Biotechnology

• HHS/FDA Tracking System Keeps an Eye on Those Suing the Agency (FDA Law Blog) (System)
• FDA issues CRL on Eli Lilly's empagliflozin, noting manufacturing deficiencies (Pharma Letter-$) (WSJ-$) (MedPage Today) (Press) (Reuters) (Pink Sheet-$) (Press) (PMLive) (Pharmafile) (Fierce) (Pharma Times) (BioCentury) (Fierce) (SCRIP-$) (Law 360-$) (Bloomberg)
• Obama looks to shorten biologics exclusivity (BioCentury)
• Upcoming FDA AdComm for Novartis' Serelaxin BLA (FDA)
• A Little Late, But CMC Annual Reportable Postapproval Changes Guidance Hits the Street (Lachman)
• 5 Takeaways From FDA's Off-Label Promotion Guidance (Law 360-$)
• FDA Seeks Genome Sequencer to Assess Safety of FDA-Regulated Products (FDA)
• CDER Advisory Panel Vacancies Remain High As Overall FDA Rates Improve (Pink Sheet-$)
• Citizen Petition Seeks Approval for Lower-Dose Versions of Purdue's Dilaudid (FDA)
• FDA Approves Endo's Aveed (Testosterone Undecanoate) Injectable Testosterone Replacement Therapy For Low-T (Press) (Reuters)
• Lupin gets USFDA nod to market generic version of Cipro (India Times)
• Aegerion Warns About Negative Impact Of DOJ Investigation (Forbes)
• Risky Business: The FDA And Drug Development For The Fatally Ill (Forbes)
• Baxter recalls a dialysis product due to mold (Fierce) (FDA)
• Sagent recalls drug because of leaking bags (Fierce)

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

• AAA Receives Orphan Drug Designation for Gallium-68 Dotatate (Press)
• Boehringer reports Phase III mild asthma data; no word on NDA filing (SCRIP-$) (Press)
• Merck's Investigational Hepatitis C Treatment Regimen MK-5172/MK-8742 Shows Robust Anti-HCV Activity in HIV/HCV Co-Infected Patients with HCV Genotype 1 Infection (Press)
• US: Pharmaceuticals and Biotechnology: General
• Lawsuit challenges Arizona's limits on use of abortion drug (Reuters)
• New Notre Dame research center to focus on drug discovery and development (Press)
• Delaware Can't Get Lethal Injection Drugs (AP)

US: Medical Devices

• When Does an App Become a Medical Device? (MDDI)
• Citizen Petition Seeks Exemption of Manually Operated Portable Wheelchair Lifts from 510(k) Requirements (FDA)
• Mauna Kea Technologies Receives 510(k) Regulatory Clearance from U.S. FDA for Cellvizio in Urology (Press)

US: Assorted And Government

• U.S. fears for patents on next-generation drugs in India (Reuters)
• How Google Is Trying to Protect Your Drug Supply (National Journal)
• P&G Tech Toothbrush May Foretell OTC Switch Future (Tan Sheet-$)
• Alliance "Disappointed" by President's FY 15 Budget Request (StrengthenFDA)
• PhRMA Pans President's Budget Request (PhRMA)

Europe

• EU Parliament may forge ahead on medtech regulations vote without Council (Clinica-$)

India

• Flies Found By FDA Threaten Indian Town Built on Generics (Bloomberg)
• India defends regulatory system against 'direct assault' (SCRIP-$)
• Novartis may face tough action over 'fake' documents in India (SCRIP-$)

General Regulatory And Interesting Articles

• Artificial Organs May Finally Get a Blood Supply (MIT Tech Review)
• Clinical Trials of Primary Care Drugs: Could Smaller Be Better? (Health Reform Watch)
• Impact Of Strategic Outsourcing On QA Oversight By Sponsor Companies (Life Science Leader)

Regulatory Reconnaissance #270 - 6 March 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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Need to contact the editor of Regulatory Reconnaissance? Find him on Twitter at @AlecGaffney or send him an email at [email protected].