Documents
Briefs, oral arguments, agency decisions and the Federal Register.
5,436 results
0.82s
Additional Safeguards for Children in Clinical Investigations of FDA-Regulated Products
Federal Register · Rule · Apr 24, 2001
FDA anticipates that among the types of procedures that might be used in a clinical investigation that would present no more than minimal risk to children would be clean-catch urinalysis, obtaining stool … These reviews are to occur during the first periodic review following the implementation of this rule or sooner, at the discretion of the IRB.
66 FR 20589Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Jan 16, 2025
However, many comments argued that the implementation period should be significantly longer than a 1- or 2-year period to allow farmers, tobacco intermediaries, and manufacturers to develop and implement … Some comments stated that a 60-day selloff period would be a sufficient selloff period while still maintaining the public health goals of the standard.
90 FR 5032Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Jan 29, 2020
Section 1003(d)(2)(C) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to conduct research relating to drugs and other FDA regulated products in carrying … out the provisions of the FD&C Act.
85 FR 5213Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Sep 12, 2007
Background Section 204 of the Food and Drug Administration Modernization Act of 1997 (FDAMA) (Public Law 105-115) amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d … Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy.
72 FR 52142Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · Dec 7, 2010
DATES: Submit either electronic or written comments on this list and on any agency guidance document at any time. ADDRESSES: Submit electronic comments to http://www.regulations.gov. … Pharmaceutical Component Quality Control • Pharmaceutical Manufacturing Statistics • Pre-Launch Activities Importation Request (PLAIR) • Prevention and Control of Viral Contamination • Validation of Air
75 FR 76011Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Feb 4, 2022
(FD&C Act). … (ii) Validation testing results demonstrating the ability of the pump to detect relevant hazards associated with drug delivery and the route of administration ( e.g., occlusions, air in line, etc.)
87 FR 6422Health and Human Services DepartmentFood and Drug AdministrationNational Environmental Policy Act; Revision of Policies and Procedures
Federal Register · Rule · Jul 29, 1997
The agency received four comments during this extended comment period, three of which addressed categorical exclusions for drug and biologic products. … FDA is in the process of establishing a policy for determining when uses of CFC's currently designated essential will no longer be deemed essential under the Clean Air Act due to the availability of safe
62 FR 40570Final RuleHealth and Human Services DepartmentFederal Register · Notice · Nov 15, 1999
DATES: Submit comments on this list and on agency guidance documents at any time. … Standards Act Final Regulations Document #6. Compliance Guidance: The Mammography Quality Do. Standards Act Final Regulations Document #7.
64 FR 61881Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Notice · May 2, 1997
DATES: Written comments by June 16, 1997. … Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document.
62 FR 24302Health and Human Services DepartmentFood and Drug AdministrationMedical Devices; Exemptions From Premarket Notification; Class II Devices
Federal Register · Rule · Nov 3, 1998
(the act) … (the act)
63 FR 59222Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 17, 1999
(the act) (21 U.S.C. 321(p)). … Request for Comments Interested persons may, on or before November 15, 1999, submit written comments to the Dockets Management Branch (address above).
64 FR 44671Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Nov 27, 1995
Two copies of any comments are to be submitted, except that individuals may submit one copy. Comments are to be identified with the docket number found in brackets in the heading of this document. … , 355, 357, 371); secs. 215, 301, 351 of the Public Health Service Act (42 U.S.C. 216, 241, 262). 2.
60 FR 58229Health and Human Services DepartmentFood and Drug AdministrationTobacco Product Standard for Menthol in Cigarettes
Federal Register · Proposed Rule · May 4, 2022
that demonstrates good cause for a referral and is made before the expiration of the comment period. … “Proposed Identification of Environmental Tobacco Smoke as a Toxic Air Contaminant.” CEPA, Air Resources Board, Office of Environmental Health Hazard Assessment, 2005.
87 FR 26454Health and Human Services DepartmentFood and Drug AdministrationNomenclature Change for Dockets Management; Technical Amendment
Federal Register · Rule · Jul 14, 2023
Publication of this document constitutes final action on the changes under the Administrative Procedure Act (5 U.S.C. 553). … FDA has determined that notice and public comment are unnecessary because this amendment to the regulations provides only a technical change to update the organizational information for Dockets Management
88 FR 45063Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Rule · Dec 23, 2002
Total nasal air flow rates were measured prior to dosage and at timed intervals up to 8 hours. … section 505(a) of the act
67 FR 78158Health and Human Services DepartmentFood and Drug AdministrationFederal Register · Proposed Rule · Aug 11, 1995
Credibility is reinforced when the message is felt to apply personally to the reader or which describes a risk which may be felt by the reader to concern them personally.'' 230 During the comment period … Specifically, they do not prevent broadcasters from airing public service announcements regarding the dangers of tobacco use and they likewise would not prohibit tobacco manufacturers from purchasing air
60 FR 41314Regulations Restricting the Sale and Distribution of Cigarettes andProposed RuleFederal Register · Proposed Rule · Oct 1, 1999
Pneumothorax Pneumothorax is the presence of air within the thoracic cavity. … Submission of Comments Interested persons may, on or before December 30, 1999, submit to the Dockets Management Branch (address above) written comments regarding this proposal.
64 FR 53294Health and Human Services DepartmentFood and Drug AdministrationFoods and Drugs; Technical Amendments
Federal Register · Uncategorized Document · Mar 28, 1994
21 CFR Part 1030 Electronic products, Microwave ovens, Radiation protection. 21 CFR Part 1240 Communicable diseases, Public health, Travel restrictions, Water supply. 21 CFR Part 1250 Air … Section 60.20 FDA action on regulatory review period determinations is amended in paragraph (b) by removing ``Rm. 4-62, 5600 Fishers Lane,'' and adding in its place ``rm. 1-23, 12420 Parklawn Dr.,''.
Health and Human Services DepartmentFood and Drug AdministrationOral Dosage Form New Animal Drugs; Tetracycline Hydrochloride Soluble Powder
Federal Register · Uncategorized Document · Apr 14, 1994
Under section 512(c)(2)(F)(iii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360b(c)(2)(F)(iii)), these approvals do not qualify for exclusivity periods because their applications do not contain … Control of chronic respiratory disease (CRD or air-sac disease) caused by Mycoplasma gallisepticum and E. coli; control of infectious synovitis caused by M. synoviae susceptible to tetracycline.
Food and Drug AdministrationQuarterly List of Guidance Documents at the Food and Drug Administration
Federal Register · Notice · May 24, 2000
DATES: General comments on this list and on agency guidance documents are welcome at any time. … ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
65 FR 33553Health 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.