Pharm Law Cross Words PUZZLE muhaha

Edit Answers
123456789101112
Across
  1. 2. FDA database containing adverse-event reports and product-quality complaints associated with adverse events
  2. 3. Property showing that a generic delivers the same amount of active ingredient in the same amount of time as the innovator product
  3. 6. FDA designation for a drug showing preliminary clinical evidence of substantial improvement over available therapy
  4. 7. Application submitted to the FDA before an investigational drug can be tested in humans
  5. 8. Formal application requesting FDA approval to market a new prescription drugcat Likes to chase mice
  6. 11. FDA designation for drugs that treat serious conditions and fill an unmet medical need
  7. 12. FDA-required risk-management program for certain drugs with serious safety risks
Down
  1. 1. FDA safety reporting program used by healthcare professionals, patients, and consumers
  2. 4. FDA publication listing approved drug products and therapeutic equivalence evaluations
  3. 5. Clinical trial phase emphasizing safety, metabolism, excretion, and dose finding
  4. 9. Abbreviated application used for approval of generic drugs
  5. 10. National vaccine safety surveillance program co-sponsored by the FDA and CDC