139 related articles for article (PubMed ID: 29140646)
1. Early Developments in the Regulation of Biologics.
Coleman TS
Food Drug Law J; 2016; 71(4):544-607. PubMed ID: 29140646
[TBL] [Abstract][Full Text] [Related]
2. The first pharmacoepidemiologic investigations: national drug safety policy in the United States, 1901-1902.
Lilienfeld DE
Perspect Biol Med; 2008; 51(2):188-98. PubMed ID: 18453724
[TBL] [Abstract][Full Text] [Related]
3. [The history of regulatory system for plasma fractionation products in the United States].
Fukuzawa M; Tsutani K
Yakushigaku Zasshi; 2014; 49(2):205-13. PubMed ID: 25799842
[TBL] [Abstract][Full Text] [Related]
4. Early history of regulatory requirements for poultry biologics in the United States.
Espeseth DA; Lasher H
Avian Dis; 2010 Dec; 54(4):1136-43. PubMed ID: 21313831
[TBL] [Abstract][Full Text] [Related]
5. Governmental oversight of prescribing medications: history of the US Food and Drug Administration and prescriptive authority.
Plank LS
J Midwifery Womens Health; 2011; 56(3):198-204. PubMed ID: 21535368
[TBL] [Abstract][Full Text] [Related]
6. Forbidden and Permitted Statements about Medications--Loosening the Rules.
Avorn J; Sarpatwari A; Kesselheim AS
N Engl J Med; 2015 Sep; 373(10):967-73. PubMed ID: 26332553
[No Abstract] [Full Text] [Related]
7. Rethinking 'flexibilities' in the international drug control system-Potential, precedents and models for reforms.
Collins J
Int J Drug Policy; 2018 Oct; 60():107-114. PubMed ID: 28129946
[TBL] [Abstract][Full Text] [Related]
8. Adequate controls for new drugs: good manufacturing practice and the 1938 federal Food, Drug, and Cosmetic Act.
Cooper DE
Pharm Hist; 2002; 44(1):12-23. PubMed ID: 12068915
[No Abstract] [Full Text] [Related]
9. Regulation of follow-on biologics.
Frank RG
N Engl J Med; 2007 Aug; 357(9):841-3. PubMed ID: 17761588
[No Abstract] [Full Text] [Related]
10. Administrative detention of drugs intended for human or animal use. Final rule.
Food and Drug Administration, HHS
Fed Regist; 2014 May; 79(103):30716-21. PubMed ID: 24873018
[TBL] [Abstract][Full Text] [Related]
11. Bioequivalence: the regulatory career of a pharmaceutical concept.
Carpenter D; Tobbell DA
Bull Hist Med; 2011; 85(1):93-131. PubMed ID: 21551918
[TBL] [Abstract][Full Text] [Related]
12. Tobacco, public health, and the FDA.
Curfman GD; Morrissey S; Drazen JM
N Engl J Med; 2009 Jul; 361(4):402-3. PubMed ID: 19546344
[No Abstract] [Full Text] [Related]
13. Preclinical assessment of abuse liability of biologics: In defense of current regulatory control policies.
Gauvin DV; Zimmermann ZJ; Baird TJ
Regul Toxicol Pharmacol; 2015 Oct; 73(1):43-54. PubMed ID: 26107292
[TBL] [Abstract][Full Text] [Related]
14. '1996' starting the modern era of biologics regulation: FDA's elimination of establishment licensure and other changes.
Gamerman GE; Mackler BF; Landa MM
Biotechnol Appl Biochem; 1997 Jun; 25(3):189-95. PubMed ID: 9198272
[TBL] [Abstract][Full Text] [Related]
15. Biological products regulated under Section 351 of the Public Health Services Act; implementation of biologics license; elimination of establishment license and product license--FDA. Proposed rule.
Fed Regist; 1998 Jul; 63(147):40858-71. PubMed ID: 10181717
[TBL] [Abstract][Full Text] [Related]
16. The trouble with drink and drugs: why prohibition and criminalization matter.
Levine HG; Reinarman C
Addiction; 2010 May; 105(5):806-7. PubMed ID: 20402973
[No Abstract] [Full Text] [Related]
17. The Atlanta Falcon and Tono-Bungay: dietary supplements as subprime drugs.
Weissmann G
FASEB J; 2009 May; 23(5):1279-82. PubMed ID: 19406845
[No Abstract] [Full Text] [Related]
18. Framing processes in public commentary on US federal tobacco control regulation.
Roth AL; Dunsby J; Bero LA
Soc Stud Sci; 2003 Feb; 33(1):7-44. PubMed ID: 12918520
[TBL] [Abstract][Full Text] [Related]
19. Biological products regulated under Section 351 of the Public Health Service Act; implementation of biologics license; elimination of establishment license and product license; public workshop--FDA. Proposed rule; notice of workshop.
Fed Regist; 1998 Aug; 63(154):42773-4. PubMed ID: 10182565
[TBL] [Abstract][Full Text] [Related]
20. Not as easy as it may appear: using radio frequency identification technology to fulfill the Prescription Drug Marketing Act's elusive pedigree requirement.
Asamoah AK
Food Drug Law J; 2006; 61(2):385-418. PubMed ID: 16903035
[No Abstract] [Full Text] [Related]
[Next] [New Search]