Seminarios web de divulgación de la FDA y el USDA / FAS para las partes interesadas de la industria

En julio del 2020, la FDA publicó el plan titulado Nueva Era de Inocuidad Alimentaria Más Inteligente, que se aplica a los productos agrícolas frescos importados. Los elementos centrales 2 (herramientas y enfoques más inteligentes para la prevención y la respuesta a los brotes), y 4 (cultura de la inocuidad alimentaria) son especialmente relevantes. Estos elementos centrales se basan en el trabajo que la FDA ha realizado para implementar las regulaciones de la Ley de Modernización de la Inocuidad de los Alimentos (FSMA por sus siglas en inglés), incluyendo la Norma de inocuidad de los productos agrícolas frescos y el Programa de verificación de proveedores extranjeros La Norma de inocuidad de los productos agrícolas frescos de la FSMA establece normas mínimas de base científica para la producción y cosecha segura de frutas y verduras frescas. Las huertas que exportan ciertas frutas y verduras frescas a los Estados Unidos pueden estar sujetas a la PSR.  La Norma de los programas de verificación de proveedores extranjeros para los importadores de alimentos de la FSMA les exige a los importadores que verifiquen que las huertas extranjeras cumplen con la PSR.

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers
▶︎

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice
▶︎

AGDD 2025 | D2S04 - Nitrosamines: Known Issues and Practical Advice

FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes
▶︎

FDA Grand Rounds: FDA Menopausal Hormone Therapy (MHT) Labeling: Historical Context & Recent Changes

AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations
▶︎

AGDD 2025 | D1S02 - Novel Bioequivalence Study Design Recommendations

AGDD 2025 | D1S00 - Welcome and Opening Remarks
▶︎

AGDD 2025 | D1S00 - Welcome and Opening Remarks

AGDD 2025 | D2S03-1 Session 3: Q&A Discussion Panel
▶︎

AGDD 2025 | D2S03-1 Session 3: Q&A Discussion Panel

FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action
▶︎

FDA Grand Rounds - Pharmacovigilance in Practice: From Safety Signals to Regulatory Action

Financial Transparency & Efficiency of the Prescription Drug, Biosimilar, & Generic Drug User Fees
▶︎

Financial Transparency & Efficiency of the Prescription Drug, Biosimilar, & Generic Drug User Fees

FDA Webinar: Safety Assessment of Genome Editing in Gene Therapy
▶︎

FDA Webinar: Safety Assessment of Genome Editing in Gene Therapy

Conversations on Cancer: Patient first = Project Facilitate
▶︎

Conversations on Cancer: Patient first = Project Facilitate

AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards
▶︎

AGDD 2025 | D1S01 - Product-Specific Guidance for Complex Products: From Research to Standards

193rd Vaccines and Related Biological Products Advisory Committee Meeting
▶︎

193rd Vaccines and Related Biological Products Advisory Committee Meeting

AGDD 2025 | D2S04 – Session 4: Q&A Discussion Panel
▶︎

AGDD 2025 | D2S04 – Session 4: Q&A Discussion Panel

AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products
▶︎

AGDD 2025 | D2S03 - Common Deficiencies and Resolutions: Complex Drug Substance/Excipients/Products

AGDD 2025 | D1S02 - Session 2: Q&A Discussion Panel
▶︎

AGDD 2025 | D1S02 - Session 2: Q&A Discussion Panel

AGDD 2025 | D2S05 - Workshop Closing Remarks
▶︎

AGDD 2025 | D2S05 - Workshop Closing Remarks

Understanding Endpoints in Rare Disease Drug Development
▶︎

Understanding Endpoints in Rare Disease Drug Development

AGDD 2025 | D1S01 – Session 1: Q&A Discussion Panel
▶︎

AGDD 2025 | D1S01 – Session 1: Q&A Discussion Panel

AGDD 2025 | D1S03 - Day One Closing Remarks
▶︎

AGDD 2025 | D1S03 - Day One Closing Remarks

Considerations for Collecting/Using Natural History Data Fit for Use in the Regulatory Setting
▶︎

Considerations for Collecting/Using Natural History Data Fit for Use in the Regulatory Setting