Sec. 4. FDA guidance for industry on development of diagnostics and antifungal drugs and vaccines for Valley Fever
162 words·~1 min read·
/bill/116/hr/2858/ih/section-4A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue draft guidance for industry for the purposes of assisting entities seeking approval under the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 301 et seq.) or licensure under section 351 of the Public Health Service Act ( 42 U.S.C. 262 ) of antifungal therapies, diagnostics, or vaccines, specifically therapies, diagnostics, and vaccines designed to diagnose, treat, or prevent coccidioidomycosis (commonly known as Valley Fever).
Not later than 18 months after the close of the public comment period on the draft guidance issued pursuant to subsection (a), the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall finalize the draft guidance. In developing and issuing the guidance required by this section, the Secretary of Health and Human Services shall hold at least 2 public workshops.
Connectionstraces to 2
Traces to 2 documents
Citation graph
cites case law
Sec. 4
FDA guidance for industry on development of diagnostics and antifungal drugs and vaccines for Valley Fever
Cites 2Cited by 0 across 0 sources