in Bethesda, Md .
Written in English
|Series||Public Health service publication no. 50, Public Health Service publication ;, no. 50.|
|LC Classifications||RS75 .U54 1971|
|The Physical Object|
|Number of Pages||70|
|LC Control Number||77612392|
Sec. PUBLIC HEALTH SERVICE ACT 2 1 The organizational units specified in this section, other than the Agency for Health Care Pol- icy and Research, were all abolished as statutory entities by Reorganization Plan No. 3 of Although the Reorganization Plan abolished the National Institutes of Health as an agency, it. Biological Products Regulated Under Section of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License; Technical Amendment and Cosmetic Act, the Public Health Service Act, and authority delegated to the Commissioner of Data and information regarding a biological. Aug 11, · The Food and Drug Administration (FDA) is announcing a public workshop to present issues related to the agency's proposed rule entitled "Biological Products Regulated Under Section of the Public Health Service Act; Implementation of Biologics License; Elimination of Establishment License and Product License" issued recently in the Federal. Mar 14, · This post was written by Erin Janssen. The FDA has issued a series of draft guidance documents addressing an abbreviated pathway for biosimilar product development under Section (k) of the Public Health Service (PHS) Act, as amended by .
Get this from a library! Establishments and products licensed under section of the Public Health Service act.. [United States. Food and Drug Administration. Bureau of Biologics.]. The Food and Drug Administration (FDA) is amending the biologics regulations to eliminate references to establishment licenses and product licenses for all products regulated under the Public Health Service Act (the PHS Act). In lieu of filing an establishment license application (ELA) and. Regulations to control communicable diseases; 42 U.S. Code § Regulations to control communicable diseases which is section of the Public Health Service Act, to reflect the probable intent of Congress. See below. ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS AND LICENSED. section of the Public Health Service Act. (2) DRUG; DEVICE‐ The terms 'drug' and 'device' have the meanings given such terms in section of the Federal Food, Drug, and Cosmetic Act. (3) HIGH NEED CURE‐ The term 'high need cure' means a drug (as that term is defined by section.
May 01, · Section of the Public Health Service Act (PHSA) authorizes FDA to issue regulations to prevent the introduction, transmission, or spread of communicable disease. 1 That is the basic authority FDA has relied upon for 21 CFR Part It is also the authority for 21 CFR Part , which has been the basic regulation governing tissue products. Section of the Public Health Service Act [42 U.S.C. ] TITLE 42 > CHAPTER 6A > SUBCHAPTER II > Part A > § § Research and investigations generally human nutrition to health professionals and the public. In carrying out activities under this paragraph, the Secretary shall provide for the coordination of such of. Private health service establishments. where a person is apprehended under section of the Act and police request ambulance to take the person to a designated mental health service; safety or welfare or to prevent a serious threat to public health, public safety or public welfare. See disclosure of health information. Apr 01, · (b) Test article means any food additive, color additive, drug, biological product, electronic product, medical device for human use, or any other article subject to regulation under the act or under sections and F of the Public Health Service Act.