Issue link: https://www.e-digitaleditions.com/i/1171020
8 Pharmaceutical Technology REGULATORY SOURCEBOOK SEPTEMBER 2019 P h a r mTe c h . c o m and model requirements, recommendations on drug labeling based on population PK analysis, and the format and content of population PK re- ports. Specifically, the guidance discusses select- ing dosing regimens, sample sizing and scheme requirements, exposure metrics, pediatric study designs, and drug–drug interactions. Data topics discussed include study subjects, sampling sched- ules, preliminary examination of data, model de- velopment and validation, and simulations based on population PK models. FDA published the final version of its REMS guidance document, Risk Evaluation and Mitiga- tion Strategies: Modifications and Revisions Guid- ance for Industry, on July 9, 2019 (5). The guid- ance provides information on types of approved risk evaluation and mitigation strategies (REMS) and how applicants should submit changes to an approved REMS. The guidance also clarifies the differences between modifications of a REMS and revisions of a REMS. F DA t i m e f r a m e s f o r a s s e s s i n g R E M S changes—including revisions, minor modifica- tions, major modifications, modifications due to safety labeling changes, and multiple types of REMS changes—are also included in the docu- ment. An appendix provides detailed submis- sion procedures. The guidance applies to all types of REMS but does not address additional submission proce- dures that may apply to application holders pro- posing changes to a shared system and that use a drug master file for their REMS submission. In July, FDA published guidance on the content development and format of Instructions-for-Use documents (IFUs) to be submitted with a NDA or a BLA (6). The guidance was written to help applicants develop consistent content and formats across IFUs that will make patient information regarding complicated or detailed use instruc- tions easy to understand. The guidance applies to human prescription drugs, biological products, and drug-device or biologic-device combination products. It does not apply to labeling for standalone medical de- vices legally marketed under medical device ap- plication types or to labeling intended for use by healthcare providers. It also does not apply to devices regulated under a BLA, such as devices associated with blood collection and processing procedures. Quality regulations FDA made M10 Bioanalytical Method Validation available in June 2019 (7). The draft guidance, developed by the International Council for Har- monization (ICH), is intended to provide recom- mendations for the validation of bioanalytical assays for chemical and biological drug quanti- fication and their application in the analysis of study samples. The guidance describes the various elements and expectations to validate specific tests used to measure the parent and active metabolites of drugs administered in nonclinical and clini- cal studies submitted in regulatory applications for biological matrices such as plasma, blood, or serum. Biosimilars On May 21, 2019, FDA published guidance on the design and evaluation of comparative ana- Guidance Update