HEALTH RESOURCES AND SERVICES ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES: SUBMISSION TO OMB FOR REVIEW AND APPROVAL; PUBLIC COMMENT REQUEST; DATA SYSTEM FOR ORGAN PROCUREMENT AND TRANSPLANTATION NETWORK, OMB NO. 0906-0110-REVISION

WASHINGTON, Oct. 9 -- Health Resources and Services Administration has issued a notice called: Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Reque... Read More

HEALTH RESOURCES AND SERVICES ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES: SUBMISSION TO OMB FOR REVIEW AND APPROVAL; PUBLIC COMMENT REQUEST; APPLICANT ORGANIZATIONAL NATIONAL PROVIDER IDENTIFIERS AND CENTERS FOR MEDICARE & MEDICAID SERVICES CERTIFICATION NUMBERS FORM

WASHINGTON, Oct. 9 -- Health Resources and Services Administration has issued a notice called: Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Reque... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: ISSUANCE OF PRIORITY REVIEW VOUCHER; RARE PEDIATRIC DISEASE PRODUCT; ZANVASTRO (ZILGANERSEN)

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ZANVASTRO (Zilganersen). The notice was published i... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: DETERMINATION THAT LASIX (FUROSEMIDE) ORAL SOLUTION, 10 MILLIGRAMS/MILLILITER, WAS NOT WITHDRAWN FROM SALE FOR REASONS OF SAFETY OR EFFECTIVENESS

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Determination That LASIX (Furosemide) Oral Solution, 10 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of... Read More

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

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Determination of Regulatory Review Period for Purposes of Patent Extension; MONOFERRIC. The notice was published in the ... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Expande... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AMNEAL PHARMACEUTICALS OF NEW YORK, LLC; WITHDRAWAL OF APPROVAL OF ABBREVIATED NEW DRUG APPLICATION FOR CELECOXIB CAPSULES, 50 MILLIGRAMS, 100 MILLIGRAMS, 200 MILLIGRAMS, AND 400 MILLIGRAMS

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Amneal Pharmaceuticals of New York, LLC; Withdrawal of Approval of Abbreviated New Drug Application for Celecoxib Capsule... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: CHALLENGES AND SOLUTIONS IN LOT-LEVEL FOOD TRACEABILITY; PUBLIC MEETING

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Challenges and Solutions in Lot-Level Food Traceability; Public Meeting. The notice was published in the Federal Registe... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: AGENCY INFORMATION COLLECTION ACTIVITIES; SUBMISSION FOR OFFICE OF MANAGEMENT AND BUDGET REVIEW; COMMENT REQUEST; BIOLOGICS LICENSE APPLICATIONS, PROCEDURES AND REQUIREMENTS

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biologi... Read More

FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: PAR HEALTH USA LLC, U.S. AGENT FOR PH HEALTH LIMITED, ET AL.; WITHDRAWAL OF APPROVAL OF 37 ABBREVIATED NEW DRUG APPLICATIONS

WASHINGTON, Oct. 9 -- Food and Drug Administration has issued a notice called: Par Health USA LLC, U.S. Agent for PH Health Limited, et al.; Withdrawal of Approval of 37 Abbreviated New Drug Applicati... Read More

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