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

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; ALHEMO. The notice was published in the Fed... Read More


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

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; ADZYNMA. The notice was published in the Fe... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; CURRENT GOOD MANUFACTURING PRACTICES FOR POSITRON EMISSION TOMOGRAPHY DRUGS

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Curren... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: EGIS PHARMACEUTICALS LIMITED, ET.AL.; PROPOSAL TO WITHDRAW APPROVAL OF THREE ABBREVIATED NEW DRUG APPLICATIONS; OPPORTUNITY FOR A HEARING

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Egis Pharmaceuticals Limited, et.al.; Proposal To Withdraw Approval of Three Abbreviated New Drug Applications; Opportun... Read More


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

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; OJEMDA. The notice was published in the Fed... Read More


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

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; ROMVIMZA. The notice was published in the F... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: OVER-THE-COUNTER MONOGRAPH DRUG USER FEE AMENDMENTS-OTC MONOGRAPH ORDER REQUEST FEE RATES FOR FISCAL YEAR 2026

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Over-the-Counter Monograph Drug User Fee Amendments-OTC Monograph Order Request Fee Rates for Fiscal Year 2026. The not... Read More


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

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; LEQEMBI. The notice was published in the Fe... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ROUNDTABLE ON PREMARKET TOBACCO APPLICATION SUBMISSIONS FOR ELECTRONIC NICOTINE DELIVERY SYSTEMS PRODUCTS; NOTICE OF MEETING; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Roundtable on Premarket Tobacco Application Submissions for Electronic Nicotine Delivery Systems Products; Notice of Mee... Read More


FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AUTHORIZATION OF EMERGENCY USE FOR TWO ANIMAL DRUGS FOR THE TREATMENT OF NEW WORLD SCREWWORM; AVAILABILITY

WASHINGTON, Dec. 29 -- Food and Drug Administration has issued a notice called: Authorization of Emergency Use for Two Animal Drugs for the Treatment of New World Screwworm; Availability. The notice ... Read More