✦ LIBER ✦

US drug and biologic approvals in 1998

✍ Scribed by Bert Spilker; Stacey FitzSimmons; Michael Horan

Publisher: John Wiley and Sons
Year: 1999
Tongue: English
Weight: 137 KB
Volume: 48
Category: Article
ISSN: 0272-4391
DOI: 10.1002/(sici)1098-2299(199912)48:4<139::aid-ddr1>3.0.co;2-v

No coin nor oath required. For personal study only.

✦ Synopsis

The Prescription Drug User Fee Act of 1992 enhanced review resources for the Food and Drug Administration (FDA). The past 3 years have seen an unprecedented approval of 122 new drugs and 28 new biologics. Information is provided on the 39 new products approved by the

📜 SIMILAR VOLUMES

US drug and biologic approvals in 1997

✍ John F. Beary III; John D. Siegfried; Renee Tavares 📂 Article 📅 1998 🏛 John Wiley and Sons 🌐 English ⚖ 837 KB

The Prescription Drug User Fee Act of 1992 enhanced review resources for the Food and Drug Administration (FDA). The past two years have seen an unprecedented approval of 92 new drugs and 19 new biologics. Information is provided on the 49 new products approved by the FDA in 1997.

U.S. drug and biologic approvals in 1996

✍ John F. Beary III; Lara E. Robillard; Gillian R. Woollett; John D. Siegfried; Th 📂 Article 📅 1997 🏛 John Wiley and Sons 🌐 English ⚖ 176 KB 👁 1 views

Since the introduction of the Prescription Drug User Fee Act of 1992, the mean approval time for new drugs has decreased from 29.9 months (1992) to 17.8 months (1996).

U.S. drug and biologic approvals in 1994

U.S. drug and biologic approvals in 1994–1995

✍ John F. Beary III; Christina M. Duchaine; Reginald W. Rhein Jr. 📂 Article 📅 1996 🏛 John Wiley and Sons 🌐 English ⚖ 784 KB

Since the introduction of the Prescription D r u g User Fee in 1992, the mean approval time for new drugs has decreased from 29.9 months (1992) t o 19.2 months (1995). In 1994, 22 new drugs and 1 biological were approved. In 1995, 28 drugs and 2 biologicals were approved.

U.S. drug and biologic product approvals

U.S. drug and biologic product approvals during 1993

✍ John F. Beary III; C. Robert Eaton; Thomas L. Copmann; Dale E. Wierenga 📂 Article 📅 1994 🏛 John Wiley and Sons 🌐 English ⚖ 485 KB 👁 1 views

Approval process and access to prescript

Approval process and access to prescription drugs in Canada

✍ Marra, Carlo A. ;Lynd, Larry D. ;Anis, Aslam H. ;Esdaile, John M. 📂 Article 📅 2006 🏛 John Wiley and Sons 🌐 English ⚖ 48 KB 👁 2 views

Drug evaluation and approval process in

Drug evaluation and approval process in the European Union

✍ San Miguel, M. Teresa ;Vargas, Emilio 📂 Article 📅 2006 🏛 John Wiley and Sons 🌐 English ⚖ 48 KB 👁 2 views