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Biotech / Medical : Ligand (LGND) Breakout! -- Ignore unavailable to you. Want to Upgrade?

To: John O'Neill who wrote (17957)	3/26/1998 10:06:00 PM
From: RXGOLF	Respond to of 32384

John, The NDA comes much later than the IND. The New Drug Application is an application for human use of a drug pursuant to section 505(b) of the Federal FOOD, DRUG, and Cosmetic Act.It must include chemistry, scientific rationale and purpose the drug is to serve, preclinical studies,clinical studies,evaluation of safety and effectiveness, and the labeling for safe and effective use of the drug. RXGOLF

To: John O'Neill who wrote (17957)	3/26/1998 10:19:00 PM
From: RXGOLF	Respond to of 32384

John, Before a new drug can be marketed, Federal Law requires that an FDA approved NDA be effected. But even before the NDA is filed,an IND must be filed with the FDA. If the FDA does not reject the IND within 30 days after it is submitted,clinical testing of the drug on humans can begin. There are 3 phases to this I believe. 1.Pharmacology studies of the drugs toxicity, metabolism absorption, and elimination in order to find the best route of administration and safe dosage. Only a small number of people are involved. 2.Use of the drug on a limited number of patients for a specific disease treatment to further test safety. 3.Extensive clinical trials if 1. and 2. above demonstrate reasonable safety and effectiveness. Hope this help some. After the IND comes the NDA and then if the NDA is approved the drug is marketed. Even after marketing, the manufacturer must submit periodic reports to the FDA. Good night and good luck, RXGOLF