Investigational drugs, biological products, and devices.
Existing law, the federal Food, Drug, and Cosmetic Act, prohibits a person from introducing into interstate commerce any new drug unless the drug has been approved by the United States Food and Drug Administration (FDA) . Existing law requires the sponsor of a new drug to submit to the FDA an investigational new drug application and to then conduct a series of clinical trials to establish the safety and efficacy of the drug in human populations and submit the results to the FDA in a new drug application.
California AB 1668 (20152016) — Investigational drugs, biological products, and devices.
Existing law, the federal Food, Drug, and Cosmetic Act, prohibits a person from introducing into interstate commerce any new drug unless the drug has been approved by the United States Food and Drug Administration (FDA) . Existing law requires the sponsor of a new drug to submit to the FDA an investigational new drug application and to then conduct a series of clinical trials to establish the safety and efficacy of the drug in human populations and submit the results to the FDA in a new drug application.
Version chain
The bill's text revisions, in order — the diff chain from filing to enrollment.
AB 1668 CALDERON Concurrence in Senate Amendments — 77–2 (pass) · lower
Do pass, but first be re-referred to the Committee on [Appropriations] — 9–0 (pass) · upper
3rd Reading AB1668 Calderon By Stone — 38–0 (pass) · upper
Do pass. — 20–0 (pass) · lower
Do pass as amended — 7–0 (pass) · upper
AB 1668 CALDERON Assembly Third Reading — 77–2 (pass) · lower
Do pass and be re-referred to the Committee on [Business and Professions] — 18–0 (pass) · lower
Do pass, but first be re-referred to the Committee on [Business, Professions and Economic Development] — 9–0 (pass) · upper
Do pass and be re-referred to the Committee on [Appropriations] — 14–0 (pass) · lower
Placed on suspense file — 7–0 (pass) · upper
Sponsors
Calderon — primary (person)
Alejo — coauthor (person)
Allen — coauthor (person)
Bonta — coauthor (person)
Brown — coauthor (person)
Campos — coauthor (person)
Chu — coauthor (person)
Dababneh — coauthor (person)
Daly — coauthor (person)
Frazier — coauthor (person)
Galgiani — coauthor (person)
Gatto — coauthor (person)
Gipson — coauthor (person)
Gonzalez — coauthor (person)
Gray — coauthor (person)
Hadley — coauthor (person)
Jones-Sawyer — coauthor (person)
Lackey — coauthor (person)
Linder — coauthor (person)
Low — coauthor (person)
Mark Stone — coauthor (person)
McCarty — coauthor (person)
Medina — coauthor (person)
O'Donnell — coauthor (person)
Obernolte — coauthor (person)
Olsen — coauthor (person)
Rendon — coauthor (person)
Rodriguez — coauthor (person)
Roger Hernández — coauthor (person)
Runner — coauthor (person)
Salas — coauthor (person)
Stone — coauthor (person)
Waldron — coauthor (person)
Williams — coauthor (person)
Timeline
The legislative action history — every referral, reading, and vote.
2016-01-15 Read first time. To print. reading-1
2016-01-19 From printer. May be heard in committee February 18.
2016-02-04 Referred to Coms. on HEALTH and B. & P. referral-committee
2016-03-07 From committee chair, with author's amendments: Amend, and re-refer to Com. on HEALTH. Read second time and amended. reading-2, amendment-introduction, amendment-passage, reading-1
2016-03-08 Re-referred to Com. on HEALTH. referral-committee
2016-03-16 From committee: Do pass and re-refer to Com. on B. & P. (Ayes 18. Noes 0.) (March 15). Re-referred to Com. on B. & P. referral-committee, committee-passage-favorable, committee-passage
2016-03-29 From committee: Do pass and re-refer to Com. on APPR. (Ayes 14. Noes 0.) (March 29). Re-referred to Com. on APPR. referral-committee, committee-passage-favorable, committee-passage
2016-04-06 In committee: Set, first hearing. Referred to APPR. suspense file. referral-committee
2016-05-27 From committee: Do pass. (Ayes 20. Noes 0.) (May 27). committee-passage-favorable, committee-passage
2016-05-27 Read second time. Ordered to third reading. reading-2, reading-1
2016-05-31 Read third time. Passed. Ordered to the Senate. (Ayes 77. Noes 2. Page 5020.) reading-3, passage, reading-1
2016-06-01 In Senate. Read first time. To Com. on RLS. for assignment. reading-1
2016-06-09 Referred to Coms. on HEALTH and B., P. & E.D. referral-committee
2016-06-23 From committee: Do pass and re-refer to Com. on B., P. & E.D. (Ayes 9. Noes 0.) (June 22). Re-referred to Com. on B., P. & E.D. referral-committee, committee-passage-favorable, committee-passage
2016-06-28 From committee: Do pass and re-refer to Com. on APPR. (Ayes 9. Noes 0.) (June 27). Re-referred to Com. on APPR. referral-committee, committee-passage-favorable, committee-passage
2016-08-01 In committee: Referred to APPR. suspense file. referral-committee
2016-08-11 From committee: Amend, and do pass as amended. (Ayes 7. Noes 0.) (August 11). amendment-introduction, committee-passage, amendment-passage
2016-08-15 Read second time and amended. Ordered to third reading. amendment-passage, reading-2, reading-1
2016-08-18 Read third time. Passed. Ordered to the Assembly. (Ayes 38. Noes 0. Page 5117.). reading-3, passage, reading-1
2016-08-19 In Assembly. Concurrence in Senate amendments pending. May be considered on or after August 21 pursuant to Assembly Rule 77.
2016-08-23 Senate amendments concurred in. To Engrossing and Enrolling. (Ayes 77. Noes 2. Page 6157.). committee-passage-favorable, amendment-passage
2016-08-30 Enrolled and presented to the Governor at 4 p.m.
2016-09-27 Approved by the Governor. executive-signature
2016-09-27 Chaptered by Secretary of State - Chapter 684, Statutes of 2016.
Source
OpenStates / OpenCivicData bulk snapshot 2026-07-01; origin ocd-bill/2d82af8c-6ec5-47b8-949d-8e9fec1ea823. Confidence: reported (aggregated from official California legislature records).