ABSTRACT
The dynamic and continuously evolving field of ophthalmology necessitates rigorous regulatory oversight in the United States. This review outlines the multifaceted Food and Drug Administration's (FDA) approval process for ophthalmic products, detailing the classifications, pathways, and regulatory compliance for devices, drugs, biologics, and combination products. Particular emphasis is placed on distinct frameworks for Class I, II, and III devices, as well as regulations for drugs, biologics, and combination products. The organizational structure of the FDA is detailed, with highlights on specific Ophthalmology oversight divisions, historical regulatory evolution, and initiatives such as Patient-Focused Drug Development. An in-depth examination of the regulatory journey, ranging from initial research to post-marketing surveillance, includes practical guidance through stages such as Pre-Investigational New Drug/Pre-Submission consultations, clinical trials, new drug application/biologics license application/premarket approval submissions, and FDA advisory committee interactions. The article underscores the importance of early interactions with the health authorities, interdisciplinary team collaboration, adherence to current standards, and the anticipation of policy changes to ensure patient safety. It concludes with an analysis of 4 key FDA-approved ophthalmic products, including Eylea®, Luxturna®, Alphagan P®, and the Raindrop® Near Vision Inlay, detailing their contributions to ophthalmic care and offering valuable insights into their respective clinical trials, regulatory pathways, and potential implications. These case studies are included to illustrate both successful and failed ophthalmic product launches, thereby highlighting the importance of alignment with regulatory compliance.
Subject(s)
Awards and Prizes , Biological Products , United States , Humans , United States Food and Drug Administration , Drug Approval , Pharmaceutical PreparationsABSTRACT
BACKGROUND: The addition of functional electrical stimulation (FES) to treadmill gait training with partial body weight support (BWS) has been proposed as a strategy to facilitate gait training in people with hemiparesis. However, there is a lack of studies that evaluate the effectiveness of FES addition on ground level gait training with BWS, which is the most common locomotion surface. OBJECTIVE: To investigate the additional effects of commum peroneal nerve FES combined with gait training and BWS on ground level, on spatial-temporal gait parameters, segmental angles, and motor function. METHODS: Twelve people with chronic hemiparesis participated in the study. An A1-B-A2 design was applied. A1 and A2 corresponded to ground level gait training using BWS, and B corresponded to the same training with the addition of FES. The assessments were performed using the Modified Ashworth Scale (MAS), Functional Ambulation Category (FAC), Rivermead Motor Assessment (RMA), and filming. The kinematics analyzed variables were mean walking speed of locomotion; step length; stride length, speed and duration; initial and final double support duration; single-limb support duration; swing period; range of motion (ROM), maximum and minimum angles of foot, leg, thigh, and trunk segments. RESULTS: There were not changes between phases for the functional assessment of RMA, for the spatial-temporal gait variables and segmental angles, no changes were observed after the addition of FES. CONCLUSION: The use of FES on ground level gait training with BWS did not provide additional benefits for all assessed parameters.
CONTEXTUALIZAÇÃO: A adição da estimulação elétrica funcional (EEF) ao treino de marcha em esteira, com sistema de suporte parcial de peso corporal (SPPC), tem sido proposta como estratégia para melhorar a marcha em hemiparéticos. Entretanto, nenhum estudo verificou a eficácia da adição da EEF ao treino de marcha com SPPC em piso fixo, a superfície mais habitual de locomoção. OBJETIVO: Investigar os efeitos da adição da EEF do nervo fibular comum, ao treino de marcha com SSPC, em piso fixo, sobre os parâmetros espaço-temporais da marcha, ângulos segmentares e função motora. MÉTODOS: Participaram do estudo 12 hemiparéticos crônicos. O sistema adotado foi o A1-B-A2. A1 e A2 corresponderam ao treino em piso fixo com SPPC, e B, ao mesmo treino, associado à EEF. As avaliações foram realizadas por meio da Escala de Ashworth Modificada (EAM), da Categoria de Deambulação Funcional (CDF), da Avaliação Motora de Rivermead (AMR) e de filmagens. As variáveis cinemáticas analisadas foram: velocidade média de locomoção; comprimento do passo; comprimento, velocidade e duração da passada; duração dos períodos de apoio duplo inicial e final, apoio simples e balanço; ângulos máximos e mínimos e amplitude de movimento (ADM) dos segmentos pé, perna, coxa e tronco. RESULTADOS: Na AMR, não houve alterações entre as fases. Para as variáveis espaço-temporais e ângulos segmentares, não houve nenhuma alteração após a adição da EEF. CONCLUSÃO: A adição da EEF ao treino de marcha em piso fixo com SPPC não promoveu melhora adicional nos parâmetros mensurados.
Subject(s)
Female , Humans , Male , Middle Aged , Body Weight , Electric Stimulation Therapy , Gait Disorders, Neurologic/rehabilitation , Physical Therapy Modalities , Stroke/rehabilitation , Combined Modality Therapy , Gait Disorders, Neurologic/etiology , Stroke/complicationsABSTRACT
BACKGROUND: The addition of functional electrical stimulation (FES) to treadmill gait training with partial body weight support (BWS) has been proposed as a strategy to facilitate gait training in people with hemiparesis. However, there is a lack of studies that evaluate the effectiveness of FES addition on ground level gait training with BWS, which is the most common locomotion surface. OBJECTIVE: To investigate the additional effects of commum peroneal nerve FES combined with gait training and BWS on ground level, on spatial-temporal gait parameters, segmental angles, and motor function. METHODS: Twelve people with chronic hemiparesis participated in the study. An A1-B-A2 design was applied. A1 and A2 corresponded to ground level gait training using BWS, and B corresponded to the same training with the addition of FES. The assessments were performed using the Modified Ashworth Scale (MAS), Functional Ambulation Category (FAC), Rivermead Motor Assessment (RMA), and filming. The kinematics analyzed variables were mean walking speed of locomotion; step length; stride length, speed and duration; initial and final double support duration; single-limb support duration; swing period; range of motion (ROM), maximum and minimum angles of foot, leg, thigh, and trunk segments. RESULTS: There were not changes between phases for the functional assessment of RMA, for the spatial-temporal gait variables and segmental angles, no changes were observed after the addition of FES. CONCLUSION: The use of FES on ground level gait training with BWS did not provide additional benefits for all assessed parameters.
