Faster access to drugs for serious or life-threatening illnesses through use of the accelerated approval regulation in the United States

Drug Information Journal

Volumn 32, Issue 1, 1998, Pages 27-35

  Cocchetto, David M ^a   Jones, Douglas R ^a  

^a GLAXOSMITHKLINE   (United States)

Author keywords

Accelerated approval; Regulatory affairs; Serious or life threatening illnesses; United States

Indexed keywords

ANTIVIRUS AGENT; DIDANOSINE;

ADVANCED CANCER; ANTIVIRAL ACTIVITY; CANCER CHEMOTHERAPY; CYSTIC FIBROSIS; DISEASE ACTIVITY; DISEASE SEVERITY; DRUG APPROVAL; DRUG BIOAVAILABILITY; FOLLOW UP; HUMAN IMMUNODEFICIENCY VIRUS INFECTION; MORBIDITY; PARKINSON DISEASE; PREDICTION; PRIORITY JOURNAL; REVIEW; SCLEROSIS; SURVIVAL RATE; UNITED STATES;

EID: 0031894352     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159803200105     Document Type: Review

References (25)

1. Food and Drug Administration. New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval. Proposed rule. Federal Register. April 15, 1992;57:13234-13242.
2. Food and Drug Administration. New Drug, Antibiotic, and Biological Drug Product Regulations; Accelerated Approval. Final rule. Federal Register. December 11, 1992;57:58942-58960.
3. Kessler DA. Issues in approving drugs for AIDS treatment. Regul Aff. 1994;6:189-200.
4. Kessler DA, Feiden KL. Faster evaluation of vital drugs. Scientif Am. March 1995;272 (No. 3):48-54.
5. Klein R. FDA s role in the treatment of HIV/AIDS. Regul Aff. 1994;6:221-227.
6. Shulman SR, Brown JS. The Food and Drug Administration's early access and fast-track approval initiatives: how have they worked? Food Drug Law J. 1995;50:503-531.
7. President Bill Clinton, Vice President Al Gore. Reinventing the Regulation of Cancer Drugs. Accelerating Approval and Expanding Access. National Performance Review. March 1996.
8. Glaxo Wellcome Epivir AIDS therapy review complete in four-and-a-half month accelerated approval process; product is first-line for use with AZT. F-D-C Reports - The Pink Sheet, November 27, 1995;6-7.
9. Roche Invirase/Hivid combination reduces mortality risk by 68%. F-D-C Reports - The Pink Sheet. October 7, 1996;T&G-5.
10. Agouron Viracept to be compared to Norvir in clinical endpoint study. F-D-C Reports - The Pink Sheet. March 17, 1997;T&G-1.
11. Pharmacia & Upjohn Rescriptor 15.1 % rebate available to AIDS Drug Assistance Programs; clinical endpoint trials of combination with processes planned. F-D-C Reports - The Pink Sheet. April 14, 1997;11-12.
12. Rhone-Poulenc Rorer Taxotere lower doses examined in ongoing studies; FDA committee recommends approval for anthracycline-resistant breast cancer. F-D-C Reports - The Pink Sheet. October 23, 1995;11-12.
13. RPR Taxotere June launch likely following accelerated approval May 14; firm to submit studies of Taxotere v. Bristol's Taxol, doxorubicin in breast cancer. F-D-C Reports - The Pink Sheet. May 20, 1996;3-5.
14. US Bioscience's Ethyol. F-D-C Reports - The Pink Sheet. March 25, 1996.
15. US Bioscience Ethyol to be marketed in US by Alza via $35 mil. deal. F-D-C Reports - The Pink Sheet. December 18, 1995;T&G-2 to T&G-3.
16. Zeneca Casodex for advanced prostate cancer receives accelerated approval from FDA; agency awaits completion of Eulexin comparison for full approval. F-D-C Reports - The Pink Sheet. October 9, 1995;7.
17. Pharmacia & Upjohn Camptosar for colorectal cancer to be available within six weeks; data to support full approval to be submitted to FDA in two years. F-D-C Reports - The Pink Sheet. June 24, 1996;7-8.
18. Sequus Doxil for AIDS-related Kaposi's sarcoma gains accelerated approval Nov. 17; studies in breast, ovarian and liver solid tumors are under way. F-D-C Reports - The Pink Sheet. November 27, 1995;7-8.
19. Pharmacia's Zinecard full approval depends on Phase IV breast cancer study; cardioprotector must show delayed progression or survival benefit. F-D-C Reports - The Pink Sheet. June 5, 1995;6-7.
20. Abbott Biaxin for MAC recommended for accelerated approval as lead agent in combination therapy by PDA Antiviral Drugs Advisory Committee May 10. F-D-C Reports - The Pink Sheet. May 17, 1993; 10-11.
21. Abbott Biaxin for MAC therapy has $1,800 annual cost. F-D-C Reports - The Pink Sheet. January 3, 1994;T&G-1 to T&G-2.
22. Pulmozyme development may be prototype for other biotech products; Genentech declined to skip Phase III or rush PLA filing; Roche financial security helped. F-D-C Reports - The Pink Sheet. January 3, 1994;8-10.
23. Milestones in Betaseron approval process. Food and Drug Administration. News Release P93-31; July 23, 1993.
24. Serono Serostim hGH approved Aug. 23 for AIDS wasting. F-D-C Reports - The Pink Sheet. August 26, 1996;T&G-1.
25. Roberts ProAmatine to be introduced in mid-October. F-D-C Reports - The Pink Sheet. September 16, 1996;T&G-2 to T&G-3.