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FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT VIBRAMYCIN (DOXYCYCLINE) FOR ORAL SUSPENSION, EQUIVALENT 25 MILLIGRAMS BASE/5 MILLILITER, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Determination That VIBRAMYCIN (Doxycycline) for Oral Suspension, Equivalent 25 Milligrams Base/5 Milliliter, Was Not Wit... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: TEVA PHARMACEUTICALS USA, INC., ET AL.; WITHDRAWAL OF APPROVAL OF 23 ABBREVIATED NEW DRUG APPLICATIONS; CORRECTION

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Teva Pharmaceuticals USA, Inc, et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction. The ... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ELECTRONIC STUDY DATA SUBMISSION; DATA STANDARDS; CLINICAL DATA INTERCHANGE STANDARDS CONSORTIUM DATASET-JAVASCRIPT OBJECT NOTATION; REQUEST FOR COMMENTS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Electronic Study Data Submission; Data Standards; Clinical Data Interchange Standards Consortium Dataset-JavaScript Obje... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT NASCOBAL (CYANOCOBALAMIN) NASAL SPRAY, 0.5 MILLIGRAM/SPRAY, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Determination That NASCOBAL (Cyanocobalamin) Nasal Spray, 0.5 Milligram/Spray, Was Not Withdrawn From Sale for Reasons o... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT DECADRON (DEXAMETHASONE SODIUM PHOSPHATE) SOLUTION/DROPS, EQUIVALENT TO 0.1 PERCENT PHOSPHATE, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Determination That DECADRON (Dexamethasone Sodium Phosphate) Solution/Drops, Equivalent to 0.1 Percent Phosphate, Was No... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT ETHYOL (AMIFOSTINE) FOR INJECTION, 500 MILLIGRAMS/VIAL, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Determination That ETHYOL (Amifostine) for Injection, 500 Milligrams/Vial, Was Not Withdrawn From Sale for Reasons of Sa... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: TYPE VII VETERINARY MASTER FILE FOR RESEARCH AND DEVELOPMENT AND RISK REVIEWS; DRAFT GUIDANCE FOR INDUSTRY; REOPENING OF THE COMMENT PERIOD

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Reopening of... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: GE HEALTHCARE, ET AL.; WITHDRAWAL OF APPROVAL OF 18 NEW DRUG APPLICATIONS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: GE HealthCare, et al.; Withdrawal of Approval of 18 New Drug Applications. The notice was published in the Federal Regi... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: 21ST CENTURY CURES ACT: ANNUAL COMPILATION OF NOTICES OF UPDATES FROM THE SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA WEB PAGE; REQUEST FOR COMMENTS

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: 21st Century Cures Act: Annual Compilation of Notices of Updates From the Susceptibility Test Interpretive Criteria Web ... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: GROWING, HARVESTING, PROCESSING, AND DISTRIBUTION OF POPPY SEEDS-INDUSTRY PRACTICES RELATED TO OPIATE ALKALOIDS; REQUEST FOR INFORMATION; EXTENSION OF COMMENT PERIOD

WASHINGTON, April 9 -- Food and Drug Administration has issued a notice called: Growing, Harvesting, Processing, and Distribution of Poppy Seeds-Industry Practices Related to Opiate Alkaloids; Request... Read More