Department of Health and Human Services April 22, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
Extension of Order Under Sections 362 and 365 of the Public Health Service Act; Order Suspending Introduction of Certain Persons From Countries Where a Communicable Disease Exists
The Centers for Disease Control and Prevention (CDC), a component of the Department of Health and Human Services (HHS), announces an extension of an Order issued March 20, 2020, under Sections 362 and 365 of the Public Health Service Act, and associated implementing regulations, that suspends the introduction of certain persons from countries where an outbreak of a communicable disease exists. The Order was issued on April 20, 2020 and shall remain in effect until 11:59 p.m. EDT on May 20, 2020. This Order may be amended or rescinded prior to that time at the discretion of the Director.
Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted Under a Biologics License Application, New Drug Application, or Abbreviated New Drug Application; Draft Guidance for Industry and Food and Drug Administration; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry and FDA entitled ``Technical Considerations for Demonstrating Reliability of Emergency- Use Injectors Submitted under a BLA, NDA or ANDA.'' For injectable drug or biological products that are intended to treat emergent, life- threatening conditions, it is essential to ensure that the emergency- use injector will reliably deliver the drug or biological product as intended. This is particularly critical for drugs when failure of the injector may prevent adequate delivery of a life-saving drug to a patient. The draft guidance describes the technical considerations for demonstrating reliability of emergency-use injectors under a biologics license application (BLA), new drug application (NDA), or abbreviated new drug application (ANDA).
Nonbinding Feedback After Certain Food and Drug Administration Inspections of Device Establishments; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled ``Nonbinding Feedback After Certain FDA Inspections of Device Establishments.'' FDA is issuing this guidance to comply with the FDA Reauthorization Act of 2017 (FDARA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance identifies a standardized method for communicating and submitting requests for nonbinding feedback and describes how FDA evaluates and responds to such requests.
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