If it gets full approval, some of the key provisions include allowing the FDA to grant market approval of a drug based on its early stage testing for safety and effectiveness. Medical-device makers would be able to apply for “breakthrough designation” pathway for products that treat conditions where no alternative exists, or that significantly improve upon already approved therapies. This sounds great, although we do have to keep in mind the huge lobbying effort behind this bill by big pharma and medical device makers. Easier approval means lots more $$$$$$$$,