Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.51s
Regulatory Hearing Before the Food and Drug Administration; General Provisions; Amendments
Federal Register · Proposed Rule · Sep 20, 2024
The comment period for this companion proposed rule runs concurrently with the comment period for the direct final rule. … If any significant adverse comments to the direct final rule are received during the comment period, FDA will publish, within 30 days after the comment period ends, a notice of significant adverse comment
89 FR 77058Health and Human Services DepartmentFood and Drug AdministrationPrescription Drug Product Labeling; Medication Guide Requirements; Extension of Comment Period
Federal Register · Proposed Rule · Nov 24, 1995
Accordingly, the comment period is extended to December 22, 1995. … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 13, 1995. William K. Hubbard, Acting Deputy Commissioner for Policy.
60 FR 58025Health and Human Services DepartmentFood and Drug AdministrationProposed Requirements for Accreditation Bodies of Mammography Facilities
Federal Register · Proposed Rule · Apr 3, 1996
Several comments expressed concern that this requirement would preempt section 354(m) of the PHS Act, which permits States to enact and enforce laws that are more stringent than those mandated by the MQSA … 354 of the Public Health Service Act (42 U.S.C. 263b). 2.
61 FR 14884Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; BetaseronRegister
Federal Register · Notice · Jan 4, 1994
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act became effective: May 19, 1983.
59 FR 305Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Maxalt®
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: October 1, 1992.
65 FR 4428Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Arava®
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: February 18, 1993.
65 FR 4429Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Plavix®
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: May 5, 1990.
65 FR 4430Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VitraveneTM
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: November 24, 1993.
65 FR 4434Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AzoptTM
Federal Register · Notice · Jan 27, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: August 23, 1992.
65 FR 4435Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Synercid
Federal Register · Notice · Sep 21, 2001
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective : June 22, 1994.
66 FR 48688Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 3, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 46501Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; ARICEPTSUPTM/SUP
Federal Register · Notice · Jul 18, 1997
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
62 FR 38564Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Prandin (5,312,924)
Federal Register · Notice · Jan 28, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act)(21 U.S.C. 355) became effective: April 3, 1992.
64 FR 4426Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Mar 4, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: April 29, 1990.
64 FR 10474Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; EmadineSUPTM/SUP
Federal Register · Notice · Jan 27, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: February 20, 1994.
64 FR 4116Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; AggrastatRegister
Federal Register · Notice · May 11, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: March 21, 1992.
64 FR 25350Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; STROMECTOLRegister
Federal Register · Notice · Jul 10, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: August 17, 1990.
63 FR 37398Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; FlowmaxSUPTM/SUP
Federal Register · Notice · Jul 10, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: August 19, 1987.
63 FR 37399Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PANDEL Cream
Federal Register · Notice · Jul 16, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: October 6, 1985.
63 FR 38410Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MeridiaRegister
Federal Register · Notice · Dec 28, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … The date an exemption under section 505 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: January 23, 1986.
63 FR 71493Health and Human Services DepartmentFood and Drug Administration
Ask Donna what matters in the record.
She can read the source against your case and show you exactly where the answer came from.