SCOPUS 정보 검색 플랫폼

Volumn 35, Issue 1, 2001, Pages 85-94

The effects of the prescription drug user fee act and the food and drug administration modernization act on the development and approval of therapeutic medicines

(3) Reichert, J M a Chee, J a Kotzampaltiris, C S a

a TUFTS UNIVERSITY SCHOOL OF MEDICINE (United States)

Author keywords

Biopharmaceutical: Drug development; Food and Drug Administration Modernization Act; Prescription Drug User Fee Act; Regulatory review

Indexed keywords

BIOTECHNOLOGY; DRUG INDUSTRY; DRUG INFORMATION; DRUG PROGRAM; FEE; FOOD AND DRUG ADMINISTRATION; PRESCRIPTION; PRIORITY JOURNAL; REVIEW;

EID: 0035091567 PISSN: 00928615 EISSN: None Source Type: Journal
DOI: 10.1177/009286150103500109 Document Type: Review

Times cited : (10)

References (11)

1
- 0005746889
- Prescription Drug User Fee Act of 1992. US Public Law 102-571 (1992 Oct 29): 21 USC 379; 106 Stat 4491

2
- 0005697393
- Food and Drug Administration Modernization Act of 1997. US PubLic Law 105-115 (1997 Nov 21); 21 USC 355a: 111 Stat 2296

3
- 0030033574
- The Prescription Drug User Fee Act of 1992: A five-year experiment for industry and the FDA
- (1996) Pharmacoeconomics , vol.9 Feb , Issue.2 , pp. 121-133
- Shulman, S.R.¹ Kaitin, K.I.²

4
- 84993803536
- The US Food and Drug Administration Modernization Act of 1997
- (1997) Bio-Science Law Review , vol.4 , pp. 127-140
- Kuhlik, B.N.¹

5
- 0005663229
- Rockville, MD: US Food and Drug Administration; April
- (1994) Progress in achieving the performance goals referenced in the Prescription Drug User Fee Act of 1992. First Report to Congress for the Period September 1, 1992 through September 30, 1993

6
- 0005765151
- Rockville, MD: US Food and Drug Administration; Dec
- (1994) Second annual performance report: Prescription Drug User Fee Act of 1992. Fiscal Year 1994 Performance Report to Congress

7
- 0005745059
- Rockville, MD: US Food and Drug Administration; Dec
- (1995) Third annual performance report: Prescription Drug User Fee Act of 1992. Fiscal Year 1995 Performance Report to Congress

8
- 0005746890
- Rockville, MD: US Food and Drug Administration; Dec
- (1996) Fourth annual performance report: Prescription Drug User Fee Act of 1992. FY 1996 Performance Report to Congress

9
- 0005685663
- Rockville, MD: Food and Drug Administration; Dec
- (1997) Final performance report: Prescription Drug User Fee Act of 1992. Fiscal Year 1997 Report to Congress

* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.