Department of Health and Human Services June 25, 2010 – Federal Register Recent Federal Regulation Documents
Results 1 - 19 of 19
Government-Owned Inventions; Availability for Licensing
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Termination of Declarations Justifying Emergency Use Authorizations of Certain In Vitro Diagnostic Devices, Antiviral Drugs, and Personal Respiratory Protection Devices
The Food and Drug Administration (FDA) is issuing this notice, under the Federal Food, Drug, and Cosmetic Act (the act), of the termination of the declarations of emergency justifying Emergency Use Authorizations (EUAs) of certain in vitro diagnostic devices, personal respiratory protection devices, and antiviral products that were issued in response to the public health emergency involving 2009 H1N1 Influenza. Advance notice of the termination of the declarations was provided under the act.
Legislative Changes to Nursing Student Loan Program Authorized Under Title VIII of the Public Health Service Act
On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act (ACA), Public Law (Pub. L.) 111-148. Section 5202 of the ACA changes the Nursing Student Loan (NSL) program by: (1) Increasing the limits of loan funds to students; (2) revising the date of enrollment to be considered eligible to receive NSL funds; and (3) revising the date of loans eligible for partial loan cancellation.
Guidance for Industry and Food and Drug Administration Staff; In Vitro Diagnostic Studies-Frequently Asked Questions; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``In Vitro Diagnostic (IVD) Device StudiesFrequently Asked Questions.'' FDA is issuing this guidance to assist manufacturers in developing and conducting studies for IVD devices, particularly those exempt from most of the Investigational Device Exemption (IDE) regulations. The guidance explains data considerations that ultimately will affect the quality of the premarket submission. The draft of this guidance was issued October 25, 2007.
Determination That DELALUTIN (hydroxyprogesterone caproate) Injection, 125 Milligrams/Milliliter and 250 Milligrams/Milliliter, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that DELALUTIN (hydroxyprogesterone caproate) injection, 125 milligrams (mg)/milliliter (mL) and 250 mg/mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydroxyprogesterone caproate injection, 125 mg/mL and 250 mg/mL, if all other legal and regulatory requirements are met. However, in considering whether to file an ANDA for hydroxyprogesterone caproate, future applicants are advised that they may not be able to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing because the product has not been commercially available for a number of years. An ANDA applicant who is unable to obtain DELALUTIN (hydroxyprogesterone caproate) injection, 125 mg/mL and 250 mg/mL, for bioequivalence testing should contact the Office of Generic Drugs for a determination of what is necessary to show bioavailability and same therapeutic effect.
Draft Guidance for Industry on Chemistry, Manufacturing, and Controls Postapproval Manufacturing Changes Reportable in Annual Reports; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``CMC Postapproval Manufacturing Changes Reportable in Annual Reports.'' This draft guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes that may be reported in annual reports. Specifically, the draft guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that FDA has determined will likely present minimal potential to have adverse effects on product quality and, therefore, may be reported by applicants in an annual report. (The draft guidance excludes positron emission tomography (PET) drug products.)
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