Department of Health and Human Services March 11, 2015 – Federal Register Recent Federal Regulation Documents
Results 1 - 5 of 5
Arthritis Advisory Committee: Notice of Postponement of Meeting
The Food and Drug Administration (FDA) is postponing the meeting of the Arthritis Advisory Committee scheduled for March 17, 2015. The meeting was announced in the Federal Register of February 10, 2015 (80 FR 7480). The postponement is due to information requests pending with the sponsor of the application. A future meeting date will be announced in the Federal Register.
Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products.'' This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or applicants relating to the development and review of drug or biological products (``products''). This draft guidance revises the guidance for industry entitled ``Formal Meetings Between the FDA and Sponsors or Applicants'' published May 19, 2009.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.