What does DSAC (CBER) mean in FDA

CBER's primary role is to provide scientific advice to the FDA with respect to medical products to help ensure their safety and efficacy. This includes evaluating pre-market clinical data submitted by applicants as part of their marketing applications; monitoring post-market clinical trials; reviewing research protocols; providing feedback on labeling; evaluating manufacturing processes; advancing science through education initiatives; developing standards; participating in external collaborations around biomarkers, diagnostics and more; developing guidance documents; participating in regulatory deliberations concerning product approvals, among other activities.

CBER evaluates pre-market data on various aspects of drug or biologic development such as chemistry manufacturing control (CMC), nonclinical studies to assess safety including toxicology studies and pharmacology/efficacy studies assessing activity in laboratory tests or animals prior to conducting any clinical trials in humans. Preclinical tests involve using test systems such as cell cultures or small animals (mice or rats) for specific endpoints such as absorption/metabolism toxicity or efficacy. Such studies are conducted prior to initiating Phase I clinical trials involving humans so that potential risks may be identified before testing in people begins. The results obtained from these preclinical studies are used by CBER scientists to advise the agency on its decision whether a product should be tested further via Phase I trial in healthy adult volunteers or directly into treating patients in Phase II/III trial(s).

Yes, after a product has been approved for marketing based on premarket review data provided by sponsors and/or manufacturers, additional information about drug's performance may be collected from post market research or surveillance programs. Such programs may include outcomes research comparing different treatments for different types of patient populations; observational studies of actual use patterns (e.g., adherence); longitudinal follow-up studies (e.g., 5 year follow up); epidemiological surveys looking at prevalence or incidence rate for various diseases within certain subpopulations e.g., pregnant women etc.; collection & comparison of adverse events reports from spontaneous reporting systems such as MEDWATCH program etc.; surveillance programs trying to detect new safety signals associated with use if certain products. So data generated from such ongoing post-market research efforts are routinely reviewed by CBER staff members assigned within relevant program areas who make sure that any emerging safety signals can be detected timely while helping FDA strengthen appropriate risk management plans which enable informed decision making regarding further product development efforts related issue management initiatives when required.

Yes! To advance science beyond evaluating products alone, CBER actively participates in many interdisciplinary collaborative efforts both internally within FDA and externally through partnerships with academia industry healthcare providers nonprofit organizations professional organizations trade associations international bodies such as WHO etc.. These collaborations offer unique opportunities while promoting an evidence based approach towards strengthening regulatory practices improving patient care ultimately reducing waste associated with ineffective treatments over utilizations etc.. International collaborations are especially important where many countries share common challenges related either to drug shortages limited access to resources including treatment options etc., so building effective partnerships across countries can go long way towards achieving optimal outcomes.