Department of Health and Human Services May 23, 2007 – Federal Register Recent Federal Regulation Documents
Results 1 - 11 of 11
Determination That Protamine Sulfate Injection and 26 Other Drug Products Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that the 27 drug products listed in this document were not withdrawn from sale for reasons of safety or effectiveness.This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) for the drug products, and it will allow FDA to continue to approve ANDAs for the products.
Determination of Regulatory Review Period for Purposes of Patent Extension; BEXTRA
The Food and Drug Administration (FDA) has determined the regulatory review period for BEXTRA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; ELAPRASE
The Food and Drug Administration (FDA) has determined the regulatory review period for ELAPRASE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL
The Food and Drug Administration (FDA) has determined the regulatory review period for GARDASIL and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Determination That ESTROSTEP 21 (Ethinyl Estradiol and Norethindrone Acetate) Tablets Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ESTROSTEP 21 (ethinyl estradiol and norethindrone acetate) tablets were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for the combination drug ethinyl estradiol and norethindrone acetate tablets, 0.02 milligram (mg)/1 mg, 0.03 mg/1 mg, and 0.035 mg/1 mg.
Determination of Regulatory Review Period for Purposes of Patent Extension; ORENCIA
The Food and Drug Administration (FDA) has determined the regulatory review period for ORENCIA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human biological product.
Medicaid Program; Graduate Medical Education
This proposed rule would clarify that costs and payments associated with Graduate Medical Education programs are not expenditures for medical assistance that are federally reimbursable under the Medicaid program.
Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop
The Agency for Healthcare Research and Quality (AHRQ) and the Food and Drug Administration (FDA) are announcing a 2-day joint public workshop entitled ``Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges.'' This public workshop is intended to seek constructive input from a wide range of stakeholders, including clinicians, pharmacists, patients, third party payers of care, the pharmaceutical and biotechnology industries, researchers, and innovators in health information technology (HIT), to help in the development and implementation of mechanisms to minimize the risks of pharmaceuticals with unusual safety and patient monitoring concerns. This meeting is an initial step that is part of FDA's commitment to monitor the performance of RiskMAPs consistent with the goal articulated in the proposed PDUFA IV agreement to undertake regular follow up of these plans.
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