Source: http://www.gxpnews.com/Whatsnew140704.html
Timestamp: 2017-03-24 10:11:07
Document Index: 559404446

Matched Legal Cases: ['art 15', 'art 882', 'art 890', 'art 558', 'arts 510', 'art 514']

Spanish FDA Drug Safety Communications:
La FDA recomienda no usar lidocaína para el tratamiento del dolor por dentición y requiere nuevo Recuadro de advertencia
No es concluyente el análisis de la FDA de riesgos cardiovasculares para diabéticos que toman el medicamento para la hipertensión olmesartán; se requieren actualizaciones a la etiqueta
Levofloxacin (LEVAQUIN) Injection (Discontinuation)
Levofloxacin (LEVAQUIN) Oral Solution (Discontinuation) FDA warns health care professionals not to use injectable vitamin products distributed by Medical Supply Liquidators with a Sunshine Labs label
FDA approves Afrezza (insulin human) to treat diabetes
Meeting Presentation: Will Government encourage innovation for the development of abuse deterrent formulations? (PDF - 370KB)
FDA review of cardiovascular risks for diabetics taking hypertension drug olmesartan not conclusive; label updates required FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne products
Mutual Pharm Co Inc
Buprenorphine Hydrochloride and Naloxone Hydrodhcloride
Confidentiality of Interim Results in Cardiovascular (CV) Outcomes Safety Trials; Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER; Request for Comments. August 11, 2014, FDA White Oak Campus, Bldg. 31, The Great Room, Silver Spring, MD. Meeting information Clinical Development of Drugs for the Prevention of Infections Caused by Staphylococcus aureus in the Health Care Setting. September 5, 2014. Meeting Information Methodological Considerations in Evaluation of Cancer as an Adverse Outcome Associated With Use of Non-Oncological Drugs and Biological Products in the Postapproval Setting; Public Meeting; Request for Comments, September, 10-11, 2014, The DoubleTree by Hilton Hotel, The Maryland Ballroom, 8727 Colesville Rd., Silver Spring, MD. 20910. Meeting information
June 27, 2014 Approval Letter - FluLaval
Posted: 7/2/2014 June 27, 2014 Approval Letter - FluLaval Quadrivalent
Posted: 7/2/2014 Approval History, Letters, Reviews and Related Documents - Eloctate
Posted: 7/2/2014 June 27, 2014 Approval Letter - FluMist
Posted: 7/1/2014 June 27, 2014 Approval Letter - Fluarix
Posted: 7/1/2014 June 27, 2014 Approval Letter - Fluarix Quadrivalent
Posted: 7/1/2014 June 27, 2014 Approval Letter - Fluzone Quadrivalent
Posted: 7/1/2014 June 27, 2014 Approval Letter - Fluzone
Posted: 7/1/2014 June 27, 2014 Approval Letter - Fluvirin
Posted: 7/1/2014 June 27, 2014 Approval Letter - Flublok
Posted: 7/1/2014 June 27, 2014 Appoval Letter - Flucelvax
Posted: 7/1/2014 Summary Basis for Regulatory Action - Eloctate (PDF - 258KB)
Posted: 6/27/2014 CBER is Moving
Updated: 06/27/14 CBER Workshops, Meetings and Conferences
Class I Medical Device Recall: Medtronic Neurosurgery, Medtronic Duet External Drainage and Monitoring System - Patient Line Tubing May Disconnect and Lead to Injury
Summary Information for: artus CMV RGQ MDx Kit
Consumer Information on: artus CMV RGQ MDx Kit - P130027
Summary Information for: Restylane Silk Injectable Gel
CDRH Workshops, Meetings and Conferences International Medical Device Regulators Forum (IMDRF), September 15-19, 2014Public Workshop - Additive Manufacturing of Medical Devices: An Interactive Discussion on the Technical Considerations of 3D Printing, October 8-9, 2014Public Workshop – Hemostatic Medical Devices for Trauma Use, September 3-4, 2014
Weekly Rule Changes - Thursday - 21 CFR Part 882 and Part 890
Wednesday - 21 CFR Part 558, Parts 510, 520, 522, 529, 556, and 558
Tuesday - 21 CFR Part 514
Medical Devices; Neurological Devices; Classification of the Transcutaneous Electrical Nerve Stimulator to Treat Headache Pages 37946	- 37948	[FR DOC # 2014-15625] PDF | Text | More
Medical Devices; Physical Medicine Devices; Classification of the Nonpowered Lower Extremity Pressure Wrap Pages 37948	- 37950	[FR DOC # 2014-15626] PDF | Text | More
Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements Pages 38036	- 38037	[FR DOC # 2014-15647] PDF | Text | More
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Antiparasitic Drug Use and Antiparasitic Resistance Survey Pages 38037	- 38039	[FR DOC # 2014-15648] PDF | Text | More
Withdrawal of Approval of Part of a New Animal Drug Application; Procaine Penicillin Pages 37621	- 37622	[FR DOC # 2014-15273] PDF | Text | More
New Animal Drugs for Use in Animal Feeds; Chlortetracycline and Sulfamethazine; Chlortetracycline; Procaine Penicillin; and Sulfamethazine Pages 37622	- 37623	[FR DOC # 2014-15274] PDF | Text | More
New Animal Drugs; Afoxalaner; Ceftiofur Crystalline Free Acid; Chloramine-T; Clodronate; Enrofloxacin; Eprinomectin; Fluralaner; Ivermectin and Praziquantel; Niclosamide; Ractopamine; Tylosin; Change of Sponsor's Address Pages 37617	- 37621	[FR DOC # 2014-15276] PDF | Text | More
Additions and Modifications to the List of Drug Products That Have Been Withdrawn or Removed From the Market for Reasons of Safety or Effectiveness Pages 37687	- 37696	[FR DOC # 2014-15371] PDF | Text | More
Final Guidance; Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Availability Pages 37742	- 37743	[FR DOC # 2014-15372] PDF | Text | More
Draft Guidance for Industry on Current Good Manufacturing Practice-Interim Guidance for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug and Cosmetic Act; Availability Pages 37743	- 37747	[FR DOC # 2014-15370] PDF | Text | More
Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act; Revised Request for Nominations Pages 37747	- 37750	[FR DOC # 2014-15367] PDF | Text | More
Bulk Drug Substances That May Be Used To Compound Drug Products in Accordance With Section 503B of the Federal Food, Drug, and Cosmetic Act, Concerning Outsourcing Facilities; Revised Request for Nominations Pages 37750	- 37754	[FR DOC # 2014-15373] PDF | Text | More
New Animal Drug Applications; Confidentiality of Data and Information in a New Animal Drug Application File; Confirmation of Effective Date Pages 37175	- 37175	[FR DOC # 2014-15209] PDF | Text | More
Office of the Commissioner; Request for Comments on the Food and Drug Administration Fiscal Year 2014-2018 Strategic Priorities Document; Request for Comments Pages 37332	- 37333	[FR DOC # 2014-15374] PDF | Text | More
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Submission of Petitions: Food Additive, Color Additive (Including Labeling), and Generally Regarded as Safe Affirmation; Submission of Information to a Master File in Support of Petitions; Electronic Submission Pages 37330	- 37332	[FR DOC # 2014-15384] PDF | Text | More
Over-the-Counter Drug Monograph System-Past, Present, and Future; Public Hearing; Reopening of the Comment Period Pages 37332	- 37332	[FR DOC # 2014-15375] PDF | Text | More