public health service act section 351

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4.860 documents for public health service act section 351

- Grants and cooperative agreements; availability, etc.: Orphan drug products; safety and effectiveness; clinical studies,
...[[Page 47340]]. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration. ... are safe and effective for approval under section 301 of the Federal Food, Drug, and Cosmetic Act (t...331 et seq.) or under section 351 of the Public Health Service Act (the PHS Act) (42...
- FR, August 08, 2003
- Notices
- Food and Drug Administration
- 21 CFR 3.2 - Definitions.
... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER A: GENERAL. PART 3:...For purposes of this section, the terms ?sponsor? and ?applicant? have the same... has the meaning given the term in section 351(a) of the Public Health Service Act (42 U.S.C. 262...
- Code of Federal Regulations - Title 21: Food and Drugs
- FDA's First Major Action On Establishing User Fees For Biosimilar Applications Under PHSA 351(K).
... and interchangeable biologics under the Public Health Service Act (PHSA), section 351(k). Under t...
- Mondaq Business Briefing
- Nbr. 2011, January 2011

- 21 CFR 60.3 - Definitions.
... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER A: GENERAL. PART 60... to the Food and Drug Administration under section 505(i), 512(j), or 520(g) of the Federal Food, Dru...(as those terms are used in the Act and the Public Health Service Act), including any salt or ester o...(i) Section 505(b) of the Act or section 351 of the Public Health Service Act (human drug produ...
- Code of Federal Regulations - Title 21: Food and Drugs
- 21 CFR 1.101 - Notification and recordkeeping.
... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER A: GENERAL. PART 1:...(a) Scope. This section pertains to notifications and records required for...381 and 382) or section 351 of the Public Health Service Act (42 U.S.C. 262). ...
- Code of Federal Regulations - Title 21: Food and Drugs
- 21 CFR 1271.150 - Current good tissue practice requirements.
... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED). SUBCHAPTER L: REGU... in ? 1271.10 and regulated solely under section 361 of the Public Health Service Act and the regul... product license application under section 351 of the Public Health Service Act) or that are devi...
- Code of Federal Regulations - Title 21: Food and Drugs
- 21 CFR 60.22 - Regulatory review period determinations.
... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER A: GENERAL. PART 60... begins on the date an exemption under section 505(i) of the Act becomes effective (or the date a... date a marketing application under section 351 of the Public Health Service Act or section 505 of...
- Code of Federal Regulations - Title 21: Food and Drugs
- 21 CFR 1301.28 - Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
... specified in paragraph (b) of this section. (2) The narcotic drugs or combination of narcotic... submit notification to the Secretary of Health and Human Services stating the individual practiti... Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act. (2) The drugs or...
- Code of Federal Regulations - Title 21: Food and Drugs
- Biological products: Workshop,
...[DOCID:fr11au98-28]. DEPARTMENT OF HEALTH AND HUMAN SERVICES. Food and Drug Administration. ...Biological Products Regulated Under Section 351 of the Public Health Service Act; Implementati...
- FR, August 11, 1998
- Proposed rules
- Food and Drug Administration
- 21 CFR 10.50 - Promulgation of regulations and orders after an opportunity for a formal evidentiary public hearing.
... AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES. SUBCHAPTER A: GENERAL. PART 10... no right to a hearing where the statutory section provides no opportunity for a hearing. (1) Section...(19) Section 351(a) of the Public Health Service Act on a biologics...
- Code of Federal Regulations - Title 21: Food and Drugs