This activity examines the regulatory landscape governing the development of medications in the United States. Overseen by the Food and Drug Administration (FDA), the process mandates a collaborative effort among drug sponsors, clinical researchers, and regulatory authorities. Navigating the drug development pipeline, from initial discovery through rigorous investigation, extensive clinical trials, and ultimate FDA approval, is crucial for ensuring the safety and efficacy of pharmaceuticals before their introduction to the consumer market. By scrutinizing federal medication development regulations, this discussion sheds light on the dynamic interactions between the FDA, drug manufacturers, and clinical researchers, offering comprehensive insights into the complexities of bringing new medications to fruition.Participants in this activity will gain a greater understanding of the multifaceted framework that guides the development of medications in the United States. The program delves into the intricacies of coordination among drug sponsors, clinical researchers, and regulatory authorities within the context of federal regulations. Examining the entire drug development process, from initial discovery to FDA approval, this activity illuminates the interplay between the key stakeholders involved. By explaining the regulatory requirements and expectations, this initiative equips healthcare professionals with the knowledge necessary to navigate the landscape of medication development, fostering a deeper appreciation for the regulatory safeguards that underpin the introduction of new pharmaceuticals to the healthcare market.
- Provider:StatPearls, LLC
- Activity Link: https://www.statpearls.com/ArticleLibrary/viewarticle/131552
- Start Date: 2023-09-01 05:00:00
- End Date: 2023-09-01 05:00:00
- Credit Details: AMA PRA Category 1 Credit™️: 1.0 hours
Nursing: 1.0 hours
Pharmacy: 1.0 hours - MOC Credit Details: ABS - 1.0 Point; Credit Type(s): Accredited CME (ABS)
ABOS - 1.0 Point; Credit Type(s): Accredited CME (ABOS)
ABPATH - 1.0 Point; Credit Type(s): Lifelong Learning (ABPATH)
ABA - 1.0 Point; Credit Type(s): Lifelong Learning (ABA)
ABTS - 1.0 Point; Credit Type(s): Accredited CME (ABTS)
ABIM - 1.0 Point; Credit Type(s): Medical Knowledge (ABIM)
ABS - 1.0 Point; Credit Type(s): Self-Assessment (ABS)
ABP - 1.0 Point; Credit Type(s): Lifelong Learning and Self-Assessment (ABP)
ABOHNS - 1.0 Point; Credit Type(s): Self-Assessment (ABOHNS)
ABTS - 1.0 Point; Credit Type(s): Self-Assessment (ABTS) - Commercial Support: No
- Activity Type: Enduring Material
- CME Finder Type: Online Learning
- Fee to Participate: Variable
- Measured Outcome: Learner Knowledge, Learner/Team Competence
- Provider Ship: Directly Provided
- Registration: Open to all
- Specialty: Adult Cardiac, All Practice Areas (e.g. ethics), Ambulatory/Outpatient, Cardiothoracic, Cardiovascular, Congenital Cardiac, Critical Care, General Operative Anesthesia, General Orthopaedics, General Otolaryngology, General Pediatrics, General Surgery, General Thoracic, Internal Medicine, Non-Thoracic Surgery