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Federal Register · Rule · May 4, 2018
Summary of Comments to the Proposed Rule The proposed rule provided a 30-day comment period. We received approximately 50,000 comments. … The comments stated that extending the compliance dates will increase the transition period from old to new versions of the Nutrition Facts label.
83 FR 19619Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 21, 2001
of the Federal Food, Drug, and Cosmetic Act (the act) and regulations governing the intersection of 180-day generic drug exclusivity and pediatric exclusivity. … ANDAs referencing the innovator drug may not be approved during the pediatric exclusivity period.
66 FR 27983Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; MycobutinSUPTM
Federal Register · Uncategorized Document · Apr 15, 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: March 23, 1986.
Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; Rotashield®
Federal Register · Notice · Feb 2, 2000
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
65 FR 4983Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CELLCEPTRegister
Federal Register · Notice · Dec 7, 1995
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
60 FR 62865Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; PATANOLSUPTM/SUP
Federal Register · Notice · May 29, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 29143Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; VERLUMASUPTM/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. … These periods of time were derived from the following dates: 1. The date an exemption under section 351 of the Public Health Service Act became effective: June 11, 1987.
63 FR 37397Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; DIFFERIN Solution
Federal Register · Notice · Jan 29, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 4300Health and Human Services DepartmentFood and Drug AdministrationDetermination of Regulatory Review Period for Purposes of Patent Extension; CEREBYXRegister
Federal Register · Notice · Mar 20, 1997
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug and Patent Term Restoration Act (Pub. … Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive.
62 FR 13387Health and Human Services DepartmentFood and Drug AdministrationAntidiarrheal Drug Products for Over-the-Counter Human Use; Final Monograph
Federal Register · Rule · Apr 17, 2003
(the act) (21 U.S.C. 321(p)) and misbranded under section 502 of the act (21 U.S.C. 352). … section 505(a) of the act
68 FR 18869Health and Human Services DepartmentFood and Drug AdministrationFood Labeling: Nutrient Content Claims, Expansion of the Nutrient Content Claim “Lean”
Federal Register · Rule · Jan 12, 2007
(Nestlé) under the Federal Food, Drug, and Cosmetic Act (the act). … For a 12-month period, all costs are assumed to be incurred in the beginning of the second year. For a 24-month period, all costs are assumed to be incurred in the beginning of the third year.
72 FR 1455Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Feb 23, 2016
ACTION: Notification; extension of comment period. … We have received a request for a 60-day extension of the comment period for the petition.
81 FR 8867Health and Human Services DepartmentFood and Drug AdministrationIrradiation in the Production, Processing, and Handling of Food
Federal Register · Rule · Aug 16, 2005
Safety Evaluation Under section 201(s) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 321(s)), a source of radiation used to treat food is defined as a food additive. … Additionally, the act does not authorize FDA to arbitrarily limit other safe alternatives.
70 FR 48057Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 26, 2000
The agency believes it is appropriate to require distributors to retain records for the same time period. … Prior to FDAMA, distributor reporting and manufacturer and distributor certification were required under the Federal Food, Drug, and Cosmetic Act (the act).
65 FR 4249Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Aug 26, 2015
ACTION: Notice of draft guidance availability and public meeting; request for comments; extension of comment period. … Food, Drug, and Cosmetic Act.
80 FR 51822Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 28, 1999
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … period.
64 FR 29046Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 18, 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: September 22, 1989.
64 FR 26986Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Nov 10, 1998
Under these acts, a product's regulatory review period forms the basis for determining the amount of extension an applicant may receive. … Furthermore, any interested person may petition FDA, on or before May 10, 1999, for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period
63 FR 63066Health and Human Services DepartmentFood and Drug Administration180-Day Generic Drug Exclusivity for Abbreviated New Drug Applications
Federal Register · Proposed Rule · Aug 6, 1999
DATES: Submit written comments by November 4, 1999. Submit written comments on the information collection requirements by September 7, 1999. … Alternative Length of Triggering Period in Specific Cases The agency is also specifically seeking comment on an alternative approach.
64 FR 42873Health and Human Services DepartmentFood and Drug AdministrationMedical Gloves; Draft Guidance Manual; Availability; Extension of Comment Period
Federal Register · Notice · Oct 28, 1999
The agency is taking this action to harmonize the comment period for the draft guidance with the extension of the comment period for the proposed rule on the reclassification of surgeon's and patient examination … Received comments may be seen in the office above between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 21, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy.
64 FR 58070Health and Human Services DepartmentFood and Drug Administration
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