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FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT REVIA (NALTREXONE HYDROCHLORIDE) TABLETS, 50 MILLIGRAMS WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Determination That REVIA (Naltrexone Hydrochloride) Tablets, 50 Milligrams Was Not Withdrawn From Sale for Reasons of S... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER VOUCHER: RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER; MRESVIA (RESPIRATORY SYNCYTIAL VIRUS VACCINE)

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; MRESVIA (Respiratory Syncy... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: INTERNATIONAL COOPERATION ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF VETERINARY MEDICINAL PRODUCTS; STABILITY TESTING FOR MEDICATED PREMIXES (REVISION 1); DRAFT GUIDANCE FOR INDUSTRY; AVAILABILITY

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products;... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION OF REGULATORY REVIEW PERIOD FOR PURPOSES OF PATENT EXTENSION; UNLOXCYT

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; UNLOXCYT. The notice was published in the ... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER PRIORITY REVIEW VOUCHER; MATERIAL THREAT MEDICAL COUNTERMEASURE PRIORITY REVIEW VOUCHER; MRESVIA (RESPIRATORY SYNCYTIAL VIRUS VACCINE)

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Priority Review Voucher; Material Threat Medical Countermeasure Priority Review Vou... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PHARMACY COMPOUNDING ADVISORY COMMITTEE; NOTICE OF MEETING; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS-BULK DRUG SUBSTANCES NOMINATED FOR INCLUSION ON THE SECTION 503A BULK DRUG SUBSTANCES LIST

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Pharmacy Compounding Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments-Bulk... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT CHEWTADZY (TADALAFIL) CHEWABLE TABLETS, 5 MILLIGRAMS, 10 MILLIGRAMS, 20 MILLIGRAMS, WERE NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Determination That CHEWTADZY (Tadalafil) Chewable Tablets, 5 Milligrams, 10 Milligrams, 20 Milligrams, Were Not Withdra... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; PROPOSED COLLECTION; COMMENT REQUEST; IMPORTATION OF PRESCRIPTION DRUGS

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Proposed Collection; Comment Request; Importation of Prescription Drugs. The... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; PROPOSED COLLECTION; COMMENT REQUEST; ORPHAN DRUGS

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs. The notice was published... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: NOTICE OF APPROVAL OF PRODUCT UNDER VOUCHER: RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHER; AREXVY (RESPIRATORY SYNCYTIAL VIRUS VACCINE, ADJUVANTED)

WASHINGTON, April 16 -- Food and Drug Administration has issued a notice called: Notice of Approval of Product Under Voucher: Rare Pediatric Disease Priority Review Voucher; AREXVY (Respiratory Syncyt... Read More