Summary of the Final Rule for the. Medicare Physician Fee Schedule for CY 2016. Table of Contents Page. Regulatory Impact Analysis 3. Determination of Practice Expense (PE) Relative Value Units (RVUs) 4. Determination of Malpractice Relative Value Units (RVUs) 5. Potentially Misvalued Services Under the Physician Fee Schedule 7.
Stability studies should include testing of those attributes of the API that. are susceptible to change during storage and are likely to inï¬ uence quality, safety and/or efï¬ cacy. The testing should cover, as appropriate, the physical, chemical, biological and microbiological attributes.
More details can be found in other guidelines (3). Results from these studies will form an integral part of the information. provided to regulatory authorities. 2.1.3 Selection of batches. Data from stability studies on at least three primary batches of the API. should normally be provided.