Waxman - Study guides, Class notes & Summaries

PTU Final ExamFood, Drug, and Cosmetic Act of 1938 - correct answer purity, strength, and safety Pure Food and Drug Act of 1906 - correct answer forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 - correct answer • Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) - correct answer Manufacturer's patient product information included with the pro...

PTU FINAL EXAM Food, Drug, and Cosmetic Act of 1938 purity, strength, and safety Pure Food and Drug Act of 1906 forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) Manufacturer's patient product information included with the product package. Hatch-Waxman Act of 1984 promoted the manufacturin...

Food, Drug, and Cosmetic Act of 1938 -Answer purity, strength, and safety Pure Food and Drug Act of 1906 -Answer forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 -Answer • Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) -Answer Manufacturer's patient product information included with the product package. Hatch-Waxman Act of 1984 -Ans...

What do clinical development group do? correct answersDevelop study protocols; manage and execute clinical plan and manage the budget. What does the Regulatory group do? correct answersNavigate the regulatory landscape through development and approval. What does the Process development group do? correct answersOptimize cell lines and manufacturing process. For biologics they consider genetic Stability, Ease of growing production cells, Yield in bioreactor, Yield of formulated product. W...

RAC sample exam 2024 | 130 Questions with 100% Correct Answers | Verified | Latest Update 2024| Graded A+ Side A - Side B Which of the following was NOT a requirement of the original Food, Drug, and Cosmetic Act of 1938? a) Proof of efficacy b) Proof of safety c) Authorized standards of identify d) Safe tolerances for unavoidable poisonous substances(1:1) - A: Proof of efficacy Which amendments to the FD&C Act resulted from the thalidomide tragedy? a) Durham-Humphrey Amendments b) Hatch...

PTU Study Guide Questions with 100% Correct Answers Graded A+ According to HIPAA, which is considered protected health information? - Co-pay amount - Prescriber's phone number - Patient's prescription record - Product's NDC number Patient's prescription record Which law requires the pharmacist to consult about new prescriptions with patients? - DSHEA - Hatch-Waxman Act - HIPPA - OBRA '90 OBRA '90 Which act requires putting a child-resistant cap on Mr. Dunn's Neur...

Food, Drug, and Cosmetic Act of 1938 correct answerspurity, strength, and safety Pure Food and Drug Act of 1906 correct answersforbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 correct answers• Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) correct answersManufacturer's patient product information included with the product package. Hatch...

Which of the following brand name products may not be substituted under New York's "negative formulary"? - Phenergan IR tablets, suppositories, solution for injection, oral suspension correct answers SUPPOSITORIES (along with ER formulations, they need to determine bioequivalence. Therapeutic equivalents that may be substituted must be... correct answers Bioequivalent and approved ANDA What are some enforcement tools utilized by the FDA? correct answers 1) Seizure of drugs 2) Criminal ...

PTU FINAL EXAM Food, Drug, and Cosmetic Act of 1938 purity, strength, and safety Pure Food and Drug Act of 1906 forbade the manufacture or transport or sale of mislabeled or adulterated food or drugs and poisonous patent medicines. Durham-Humphrey Amendment of 1951 • Created a distinction between "OTC" and "Legend Drugs". Patient Package Insert (PPI) Manufacturer's patient product information included with the product package. Hatch-Waxman Act of 1984 promoted the manufacturin...

Alabama MPJE Exam Studt Set |Question and Answers| #Latest Relaese Pure Food and Drug Act (1906) aka Wiley Law *Ans* Prohibits adulteration and misbranding Food, Drug and Cosmetic Act (1938) *Ans* -New drug could not be marketed unless safe -Required manufacturer label to have directions for use and warnings about habit forming drugs Durham-Humphrey Amendment (1951) *Ans* -Established prescription and OTC drug categories -Allowed for oral prescriptions -Allowed for refills Manufa...