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Resources for Recovery
Published in Sandra Rasmussen, Developing Competencies for Recovery, 2023
The Food and Drug Administration is a government agency established in 1906 with the passage of the Federal Food and Drugs Act. The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, dietary supplements, prescription, and over-the-counter pharmaceutical drugs, vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices, cosmetics, animal foods and feed and veterinary products. Its Center for Drug Evaluation and Research (CDER) ensures that safe and effective drugs are available to improve the health of the people in the United States.
Regulatory Issues in Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Dr. Janet Woodcock, who is currently the U.S. FDA Director of Center for Drug Evaluation and Research (CDER), once stated, “Industry must reinvent itself and its relationship with FDA to deal with a future that promises to be very different from today. Archaic regulatory practices that have stifled innovation and made the industry inefficient cannot continue. Part of the problem was that we didn’t know what influenced product quality. We treated everything the same, every deviation was a threat to product quality but if your processes are under control and well understood, we can do things very differently.” This is a clear indication tothe industry to strive for process understanding based on science and to unburden pharmaceutical manufacturing based on this understanding.
FDA Regulatory Acceptance of Bayesian Statistics
Published in Emmanuel Lesaffre, Gianluca Baio, Bruno Boulanger, Bayesian Methods in Pharmaceutical Research, 2020
The Center for Drug Evaluation and Research has been a leader in the use of Bayesian statistics in the regulation of pharmaceutical drugs in the post-market. CDER led an effort to use Bayesian data mining of safety signals in its post-market data bases and used this information to take action for various concerning safety signals that are detected. The machinery to accomplish this was a Gamma-Poisson model to borrow strength from similar drugs (DuMouchel, 1999). A major application of Bayesian methods in recent years has been the dose-finding effort for modeling a drug’s dose response curve. An early Bayesian effort was the report of the ASTIN trial (Grieve and Krams, 2005). There are now a number of examples of Bayesian adaptive designs used in dose-finding for dose establishment for Phase III studies. These studies do not use prior information but rely on accumulating information in the Phase II trial in a treatment response adaptive randomization scheme to well-characterize the dose response curve; this approach illustrates the Bayesian adaptive power of learning and confirming within the trial.
A systematic review of commercial high concentration antibody drug products approved in the US: formulation composition, dosage form design and primary packaging considerations
Published in mAbs, 2023
Indrajit Ghosh, Hiten Gutka, Mary E. Krause, Ryan Clemens, Ramesh S. Kashi
There is a tremendous urgency and need for the development and commercialization of mAb products that exceed >200 mg/mL, especially in treating immune-related disorders that require higher doses (>30–50 mg/kg) delivered by SC administration. To achieve higher mAb concentration, high solution viscosity poses a major technical hurdle that needs to be overcome. Substantial research and development efforts are ongoing in both academia and industry to identify and develop novel excipients and FDA-approved excipient combinations to reduce the viscosity of high concentration mAb products. The use and approval of novel excipients in biologics formulations has been slow, but the FDA’s Center for Drug Evaluation and Research has recently launched the voluntary Novel Excipient Review Pilot Program, which is intended to allow excipient manufacturers to obtain FDA review of certain novel excipients prior to their use in drug formulations
Is there a pathway for phosphatidylinositol 3-kinase delta inhibitors to be approved therapeutics for B-cell lymphoma therapy
Published in Expert Opinion on Pharmacotherapy, 2023
Efrat Luttwak, Mitchell R. Smith, Andrew D. Zelenetz
In subsequent commentary, members of the Center for Drug Evaluation and Research of the FDA addressed further development of this class of drugs. They advocated appropriately for careful evaluation to identify the optimal biologic dose, recommending this optimal dose be determined by a randomized trial exploring different dose levels rather than the more traditional sequential-dose cohort. The randomized trial requirement represents an enormous hurdle for early drug development and may expose more patients to potentially toxic doses. The basophil activation test (BAT), a simple flow cytometric assay, can assess PI3Kδ inhibition in vivo [15]. Thus, optimal biologic dose and schedule could be established by examining inhibition by BAT assays and development of toxicity. Importantly, the exploration of both dose and schedule is critical in optimizing PI3Kδi as there will likely be a differential impact on the tumor versus Treg. Our view is that PI3K inhibitors should be evaluated based on their individual properties, rather than assessing them as a class.
Balancing Scientific Progress With Pediatric Protections: No Direct Benefit Now, But Potential Novel Therapy in the Future
Published in The American Journal of Bioethics, 2020
Susannah W. Lee, Jessica C. Ginsberg
Generally, investigators who study new drugs must submit an IND application and receive approval from the U.S. Food and Drug Administration (Center for Drug Evaluation and Research 2015). However, clinical investigations of already FDA approved drugs may be exempt from IND requirements if all criteria for an exemption per 21 CFR §312.2(b) are met, which are (1) the drug is lawfully marketed in the U.S.; (2) the investigator does not intend to report to FDA for a new indication or significant change in labeling, or (3) advertising; (4) the investigation does not involve a route of administration, dose, patient population, or other factor that significantly increases the associated risk; (5) the investigation complies with informed consent requirements and the IRB process; and (6) the investigation does not promote the drug as safe or effective for the purposes for which it is under investigation (Food and Drug Administration 2019, 21 CFR §312.2(b)).