FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: INTERCEPT PHARMACEUTICALS, INC., ET AL.; WITHDRAWAL OF APPROVAL OF NEW DRUG APPLICATION FOR OCALIVA (OBETICHOLIC ACID) TABLETS, 5 MILLIGRAMS AND 10 MILLIGRAMS, AND THREE ABBREVIATED NEW DRUG APPLICATIONS FOR OBETICHOLIC ACID TABLETS, 5 MILLIGRAMS AND 10 MILLIGRAMS

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Intercept Pharmaceuticals, Inc, et al.; Withdrawal of Approval of New Drug Application for OCALIVA (Obeticholic Acid) Ta... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION OF REGULATORY REVIEW PERIOD FOR PURPOSES OF PATENT EXTENSION; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION SYSTEM

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; ALTIUS DIRECT ELECTRICAL NERVE STIMULATION S... Read More

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

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; ENVISION MAMMOGRAPHY PLATFORM. The notice w... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; 510(K) THIRD-PARTY REVIEW PROGRAM

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 510(k)... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: TOBACCO PRODUCTS SCIENTIFIC ADVISORY COMMITTEE; NOTICE OF MEETING; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Tobacco Products Scientific Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comment... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: REAUTHORIZATION OF THE BIOSIMILAR USER FEE ACT; PUBLIC MEETING; REQUEST FOR COMMENTS

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Reauthorization of the Biosimilar User Fee Act; Public Meeting; Request for Comments. The notice was published in the F... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; PROPOSED COLLECTION; COMMENT REQUEST; HUMAN DRUG COMPOUNDING UNDER SECTIONS 503A AND 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Proposed Collection; Comment Request; Human Drug Compounding Under Sections 50... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; EMERGENCY USE AUTHORIZATION OF MEDICAL PRODUCTS

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Emerge... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; ADMINISTRATIVE PROCEDURES FOR CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 CATEGORIZATION

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Admini... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: IMPROVING ANAPHYLAXIS OUTCOMES: APPROACHES FOR ENHANCING ACCESS TO EPINEPHRINE; PUBLIC WORKSHOP; REQUEST FOR COMMENTS

WASHINGTON, Nov. 24 -- Food and Drug Administration has issued a notice called: Improving Anaphylaxis Outcomes: Approaches for Enhancing Access to Epinephrine; Public Workshop; Request for Comments. ... Read More

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