-
1
-
-
0008217386
-
-
Food and Drug Administration Modernization and Accountability Act of 1997 Senate Report 105-43, to accompany S 830, Committee on Labor and Human Resources, 105th Congress, 1st Session
-
-
-
-
2
-
-
0008177166
-
-
Food and Drug Modernization Act of 1997, Summary prepared by the Biotechnology Industry Organization
-
(1997)
-
-
-
3
-
-
0008262416
-
-
Prepared statement of Alan Holmer, President of the Pharmaceutical Research and Manufacturers of America (PhRMA), before the House Commerce Committee
-
(1998)
-
-
-
4
-
-
4244152346
-
Loose cannons
-
(1998)
BioCentury
, vol.6
, Issue.21
-
-
-
8
-
-
0008256197
-
-
Opening Statement of Chairman James M. Jeffords, Hearing on FDA Modernization Act: implementation of the law, Senate Health, Education, Labor and Pensions Committee
-
(1999)
-
-
-
9
-
-
0032517645
-
Investigational New Drug Applications; clinical holds
-
(1998)
Federal Register
, vol.63
, Issue.239
, pp. 68676
-
-
-
10
-
-
0008178021
-
-
Prepared statement of Alan Holmer, President of the Pharmaceutical Research and Manufacturers of America, before the Senate Committee on Health, Education, Labor, and Pension
-
(1999)
-
-
-
11
-
-
0008258870
-
Converting to regulation by guidance
-
(1998)
Pharma Marketletter
, vol.25
, Issue.42
, pp. 15
-
-
-
12
-
-
0008177168
-
-
Guidance for industry: qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act Rockville, MD: Food and Drug Administration
-
(1999)
-
-
-
13
-
-
0008217387
-
-
Guidance for industry: qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act. Rockville, MD: Food and Drug Administration
-
(1998)
-
-
-
14
-
-
0008280017
-
Industry active role in guidance development urged by Wyeth's Burlington
-
(1999)
Pink Sheet
, vol.61
, Issue.40
, pp. 24
-
-
-
15
-
-
0008261883
-
-
Prepared Statement by Jane E. Henney, MD, Commissioner of Food and Drugs, Food and Drug Administration, before the Senate Committee on Health, Education, Labor and Pensions
-
(1999)
-
-
-
16
-
-
0008220182
-
-
Food and Drug Administration, Summary of FDA Public Meeting on Section 406(b) of FDA Modernization Act of 1997
-
(1998)
-
-
-
17
-
-
0008218932
-
-
CBER Stakeholders Meeting, Summary of Proceedings
-
(1998)
-
-
-
18
-
-
0008178023
-
-
Opening Statement of Edward M. Kennedy, Hearing on FDA Modernization Act: Implementation of the Law
-
(1999)
-
-
-
20
-
-
0008220367
-
-
Federal Administrative Procedure Act, 5 U.S.C. section551 et seq., sectionsec 551 (4)
-
(1991)
-
-
-
21
-
-
0008177782
-
-
Administrative Practice and Procedure. Second Edition. Charlottesville VA; Michie
-
(1991)
, pp. 627-628
-
-
Koch, C.H.1
-
23
-
-
0008261337
-
-
Testimony of Ms. Janice Bourque, Massachusetts Biotechnology Council, Hearing on the Modernization of the Food and Drug Administration, before the Senate Health, Education, Labor and Pensions Committee
-
(1999)
-
-
-
25
-
-
0033004552
-
One large, well-designed, multicenter study as an alternative to the usual FDA paradigm
-
(1999)
Drug Inf J
, vol.33
, Issue.1
, pp. 265-271
-
-
Fisher, L.D.1
-
26
-
-
0008248605
-
-
Guidance for industry: providing clinical evidence of effectiveness for human drug and biological products. Rockville, MD: Food and Drug Administration
-
(1998)
-
-
-
27
-
-
0008280020
-
-
Prescription Drug User Fee Reauthorization and Drug Regulatory Modernization Act of 1997, House Report 105-310, to accompany H.R. 1411, 105th Congress, 1st Session
-
-
-
-
28
-
-
0008218934
-
-
Guidance for industry: standards for the prompt review of efficacy supplements, including priority efficacy supplements. Rockville, MD: Food and Drug Administration
-
(1998)
-
-
-
29
-
-
0008258872
-
-
FY 1998 Performance report to Congress for the Prescription Drug User Fee Act of 1992 as amended by the FDA Modernization Act of 1997. Rockville, MD: Food and Drug Administration
-
(1999)
-
-
-
30
-
-
0008218935
-
-
Efficacy supplements approved in CY 99. Rockville, MD: Food and Drug Administration; Center for Drug Evaluation and Research
-
(1999)
-
-
-
31
-
-
0008175177
-
-
Efficacy supplements approved in CY 98. Rockville, MD: Food and Drug Administration; Center for Drug Evaluation and Research
-
(1998)
-
-
-
32
-
-
0032553158
-
Dissemination of information on unapproved/new uses for marketed drugs, biologics, and devices; final role
-
(1998)
Federal Register
, vol.63
, Issue.224
, pp. 64555
-
-
-
33
-
-
0008255767
-
Remicade off-label RA campaign cleared with balancing statement
-
(1999)
Pink Sheet
, vol.61
, Issue.23
, pp. 3-4
-
-
-
34
-
-
0008183583
-
-
United States District Court for the District of Columbia, Washington Legal Foundation v. Jane E. Henney and Donna Shalala, Order Granting Summary Judgment and Permanent Injunction, Civil Action No.1:94CV01306 (RCL)
-
-
-
-
35
-
-
0008214711
-
-
Testimony of Jane Henney, Commissioner, Food and Drug Administration, Hearing on the Modernization of the Food and Drug Administration, before the Senate Health, Education, Labor and Pensions Committee
-
(1999)
-
-
-
37
-
-
0032476883
-
Regulations requiring manufacturers to assess the safety and effectiveness of new drugs and biological products in pediatric patients
-
(1998)
Federal Register
, vol.63
, Issue.231
, pp. 66632
-
-
-
38
-
-
0008262418
-
-
Remarks by Linda Suydam, Senior Associate Commissioner, Food and Drug Administration, presented at Food and Drug Law Institute, Educational Conference, Washington, D.C.
-
(1999)
-
-
-
40
-
-
0008178024
-
Standard NDA reviews most affected by downturn in first-cycle NDA approvals Lumpkin asserts
-
(1999)
U.S. Reg Reporter
, vol.16
, Issue.4
, pp. 1-3
-
-
-
41
-
-
0031894352
-
Faster access to chugs for serious or life-threatening illnesses through use of the accelerated approval regulation in the United States
-
(1998)
Drug Inf J
, vol.32
, Issue.1
, pp. 27-35
-
-
Cocchetto, D.M.1
Jones, D.R.2
-
42
-
-
0030840825
-
Initiatives to speed new drug development and regulatory review: The impact of FDA-sponsor conferences
-
(1997)
Drug Inf J
, vol.31
, Issue.3
, pp. 771-788
-
-
DiMasi, J.A.1
Manocchia, M.2
-
43
-
-
0008175178
-
Fast track drugs may lose designation if criteria are no longer met-FDA
-
(1998)
Pink Sheet
, vol.60
, Issue.47
, pp. 32
-
-
-
45
-
-
0003192925
-
An interview with Director of the Division of Cardio-Renal Drug Products Raymond Lipicky, MD
-
(1999)
U.S. Reg Reporter
, vol.16
, Issue.4
, pp. 3-7
-
-
-
46
-
-
84996165603
-
Patients or profits?
-
(1998)
Economist
, vol.7
, pp. 15
-
-
-
47
-
-
0032740491
-
The European Agency for the Evaluation of Medicinal Products' centralized procedure for product approval: Current status
-
(1999)
Drug Inf J
, vol.33
, Issue.4
, pp. 969-978
-
-
Healy, E.M.1
Kaitin, K.I.2
-
48
-
-
0008223804
-
Pharma outpaced in global rankings
-
(1999)
Scrip
, vol.2454
, pp. 9
-
-
-
49
-
-
0008280024
-
US retail Rx sales to rise 18%
-
(1999)
Scrip
, vol.2470
, pp. 15
-
-
|