Regulatory Recon: FDA's Generic Metoprolol Mess (16 May 2014)

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In Focus: US

• Metoprolol Mess Reveals Serious Flaws With FDA's Generic Process (People's Pharmacy) (Fierce) (S4S)
• FDA issues Complete Response Letter for Novartis' serelaxin (RLX030) for acute heart failure (Press) (Fierce) (Reuters) (SCRIP-$)
• Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention (IPQ-$)
• Cambridge biotech scores big on test of Viagra as an over-the-counter ointment (BioFlash)
• UDI Exceptions, Alternatives and Time Extensions (FDA)
• Non-GMO Verification for Dietary Supplements (NPI)

In Focus: International

• Invokana set for NICE recommendation (PMLive) (Pharma Letter-$)
• First draft finished product monograph with chemically defined active substance published for comment (EDQM)
• Lilly loses UK Alimta patent case, appeal planned (SCRIP-$) (Fierce) (Reuters) (Law 360-$)
• Argentina pushes on with national device implant traceability plan (Clinica-$)

US: Pharmaceuticals/Biotechnology

• Metoprolol Mess (Toprol XL) Reveals Serious Flaws With FDA's Generic Process (People's Pharmacy) (Fierce) (S4S)
• FDA issues Complete Response Letter for Novartis' serelaxin (RLX030) for acute heart failure (Press) (Fierce) (Reuters) (SCRIP-$)
• Warning Letters from 2012 – Q1 2014 Show FDA’s GMP Enforcement Focus Shifting Overseas; Foreign Labs Draw Particular Attention (IPQ-$)
• FDA Alerts Horse Owners and Veterinarians About Adverse Events Associated with Certain Unapproved Compounded Drugs in Horses (FDA)
• Expanded Access Theme Is One Sour Note For Biopharma In “21st Century Cure” Roundtable (RPM Report-$)
• VICH GL51: Guidance for Industry on Statistical Evaluation of Stability Data (FDA) (FDA)
• Candidate Metrics for Evaluating the Impact of Prescriber Education on the Safe Use of Extended-Release/Long-Acting (ER/LA) Opioid Analgesics (PubMed)
• Cardiovascular Outcomes Trials For Opioid Agonists To Get FDA Panel Review (Pink Sheet-$)
• Jury Finds for Takeda in Diabetes Drug Case (Takeda)

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

• BI's Giotrif increases lung cancer survival (Pharmafile) (Press)
• Cambridge biotech scores big on test of Viagra as an over-the-counter ointment (BioFlash)
• Orteronel Plus Prednisone Improved Progression Free Survival in Men With Chemotherapy-Naïve Metastatic Castration Resistant Prostate Cancer in Phase 3 Study (Press)
• This vaccine just cured a 50-year old woman's cancer (Vox)
• Higher Doses of 'Abortion Pill' Safe in Cushing's? (MedPage Today)

US: Pharmaceuticals and Biotechnology: General

• Report: DOD Has Strengthened Coordination on Medical Countermeasures but Can Improve Its Process for Threat Prioritization (GAO)
• PhRMA warns out-of-pocket costs could double under O-Care (The Hill)

US: Medical Devices

• UDI Exceptions, Alternatives and Time Extensions (FDA)
• Class I Recall for Alere INRatio2 Test Strips (FDA)
• Complications in cosmetic laser surgery: a review of 494 Food and Drug Administration Manufacturer and User Facility Device Experience Reports. (PubMed)

US: Dietary Supplements

• Non-GMO Verification for Dietary Supplements (NPI)
• US: Assorted And Government
• How American Doctors Lost Their Professional Autonomy (Forbes)
• FDLI Names New President and Chief Executive Officer (FDLI)

Europe

• Invokana set for NICE recommendation (PMLive) (Pharma Letter-$)
• First draft finished product monograph with chemically defined active substance published for comment (EDQM)
• Lilly loses UK Alimta patent case, appeal planned (SCRIP-$) (Fierce) (Reuters) (Law 360-$)
• Medivir's Simeprevir approved in EU for the treatment of adults with hepatitis C genotype 1 and 4 infection (Press)
• EU tells pharma to "lobby better" in member states (Pharma Times)

Other International

• Argentina pushes on with national device implant traceability plan (Clinica-$)

Regulatory Reconnaissance #320 – 16 May 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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