The sponsor must submit an ind safety report to the fda if an adverse event is (1) serious; (2) unexpected; and:

Bandar industries berhad of malaysia manufactures sporting equipment. one of the company’s products, a football helmet for the north american market, requires a special plastic. during the quarter ending june 30, the company manufactured 35,000 helmets, using 22,500 kilograms of plastic. the plastic cost the company $171,000. according to the standard cost card, each helmet should require 0.6 kilograms of plastic, at a cost of $8 per kilogram. 1. what is the standard quantity of kilograms of plastic (sq) that is allowed to make 35,000 helmets? 2. what is the standard materials cost allowed (sq x sp) to make 35,000 helmets? 3. what is the materials spending variance? 4. what is the materials price variance and the materials quantity variance?