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Guidance on Informed Consent for Plasma Donors

06/21/2007

Federal Register Notice: FDA is making available Guidance for Industry: Informed Consent Recommendations for Source Plasma Donors ...

Guidance on Computer Crossmatch for Blood Donors

06/21/2007

Federal Register Notice: FDA is making available a draft document entitled Guidance for Industry: Computer Crossmatch (Electronic ...

Pharmacovigilance of Veterinary Medicinal Products Guidance

06/21/2007

Federal Register Notice: FDA is making available for comments, Revised Draft Guidance for Industry on Pharmacovigilance of Veterin...

Comments Sought on Device Third-Party Review

06/21/2007

Federal Register Notice: FDA is seeking public comments by 8/20 on information collection requirements for “Medical Devices ...

Comment Sought on Animal Drug User Fee Sheet

06/15/2007

Federal Register Notice: FDA solicits comments on the hourly burden necessary to complete FDA Form 3546, “Animal Drug User F...

Info on Condom Label Comprehension Sent to OMB

06/15/2007

Federal Register Notice: FDA’s proposed collection of information, “Label Comprehension Study” U.S.C. 393(d)(2)(...

Comment Sought on Device Adverse Event Collection

06/13/2007

Federal Register Notice: FDA is seeking public comment on the proposed continuation of a pilot project to evaluate the electronic ...

FDA Proposes Removing Essential Use for Inhaler Ingredients

06/11/2007

Federal Register Proposed rule: FDA is proposing to amend its regulation on the use of ozone-depleting substances in self-pressuri...

List of Approved PMAs Posted

06/07/2007

Federal Register Notice: FDA is publishing a list of premarket approval applications that have been approved to inform the public ...

Chantix Review Period Set

06/07/2007

Federal Register Notice: FDA has determined the regulatory review period for Chantix is 2,401 days for extending a patent which cl...