Angela Silva on Food and Drug Administration (FDA)

A Bevy of Recent FDA Updates on Innovation in Clinical Trial Design

Aiming to expedite drug development, enhance the body of clinical evidence supporting new and existing therapies, and improve participation and diversity in clinical trial populations, the US Food and Drug Administration...more

10/1/2024 / Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Medical Research , Pharmaceutical Industry , Prescription Drugs

FDA Issues Long-Awaited Diversity Action Plan Guidance

Recognizing the importance of diversity and inclusivity in clinical trials, drug development, and regulatory decision-making, Congress amended the Federal Food, Drug, and Cosmetic Act (FDCA) in connection with the Food and...more

8/19/2024 / Clinical Trials , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Prescription Drugs

FDA Issues Draft Guidance on Its New Platform Technology Designation Program

Taking a step toward fulfilling its requirements under Section 506K of the Federal Food, Drug, and Cosmetic Act (Section 506K), FDA has issued Draft Guidance describing how the agency intends to implement the Platform...more

6/12/2024 / Draft Guidance , Food and Drug Administration (FDA) , Life Sciences , Pharmaceutical Industry , Prescription Drugs

FDA Clarifies Distinction Between Device Remanufacturing and Servicing in Final Guidance

While the US Food and Drug Administration’s recently issued Final Guidance on Remanufacturing of Medical Devices provides clarity and attempts to reign in certain activities, the agency continues to defer enforcement for...more

5/22/2024 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices

Better Late Than Never: FDA Issues Long-Awaited Final Informed Consent Guidance

After almost a decade, the Food and Drug Administration (FDA or Agency) finalized the Informed Consent guidance document (Final Guidance). The Final Guidance finalizes the 2014 draft Informed Consent Information Sheet...more

9/18/2023 / Clinical Trials , Food and Drug Administration (FDA) , Informed Consent , IRB , Life Sciences , Medical Research

Combining the ‘Ingredients’: FDA Reorganizes Human Foods Infrastructure Under a Single Leader

In a sizable step toward reorganizing the Human Foods Program (HFP or Program) to rehaul the US Food and Drug Administration’s (FDA’s) current food infrastructure to better coordinate the agency’s regulation of food products,...more

9/14/2023 / Food and Drug Administration (FDA) , Food Manufacturers , Food Safety , Food Supply

Reassessing Drug Inspection Targets: FDA Updates Internal Policy for Risk-Based Site Selection Model

In a continuing effort to improve the quality system effectiveness of human drug manufacturing sites, FDA revised MAPP 5014.1, Understanding CDER’s Risk-Based Site Selection Model (Site Selection MAPP or the Policy)....more

7/11/2023 / Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Pharmaceutical Industry , Prescription Drugs

How the End of the PHE Will Impact the Healthcare Industry

The Biden administration announced on January 30, 2023 that the COVID-19 Public Health Emergency (PHE) would officially end on May 11, 2023. The PHE declaration, which first was issued by the Secretary of the US Department of...more

5/11/2023 / Centers for Medicare & Medicaid Services (CMS) , Department of Health and Human Services (HHS) , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medicare , OCR , Public Health Emergency , Telehealth

FDA Finalizes Framework for Transitioning from COVID-Related Medical Devices EUA/Enforcement Discretion to Permanent Marketing...

The US Food and Drug Administration has finalized the framework for transitioning medical devices previously granted emergency use authorization or subject to particular enforcement policies to obtaining permanent marketing...more

4/14/2023 / Draft Guidance , Emergency Use Authorization (EUA) , Food and Drug Administration (FDA) , Life Sciences , Medical Devices

When Words of Encouragement May Indicate More: Congress Focuses on Rare Disease Approval Process

While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US Congress indicated that it is...more

2/22/2023 / FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Orphan Drugs , Pharmaceutical Industry , Prescription Drugs

FDA Embraces Alternative Tools for Inspecting Facilities

On October 17, 2022, the US Food and Drug Administration (FDA) implemented revisions to two of its compliance policy guides (CPGs). CPGs are intended to advise FDA staff as to the agency's strategy when assessing and...more

10/21/2022 / Food and Drug Administration (FDA) , Inspections , Manufacturers , Manufacturing Facilities , Pharmaceutical Industry , Risk Management

One License to Unite Them All: FDA Proposes National Standards for Wholesale Distributors and Third-Party Logistic Providers

The US Food and Drug Administration (FDA) has issued a proposed rule—“National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers” (Proposed Rule)—pursuant to FDA’s obligations...more

5/26/2022 / Drug Distribution , DSCSA , Food and Drug Administration (FDA) , Manufacturers , Pharmaceutical Industry , Prescription Drugs , Proposed Rules , Supply Chain , Wholesale

After a Series of False Starts, FDA Resumes Domestic Inspections

FDA announced on February 2 that it would be resuming domestic surveillance inspections across all product types, beginning on February 7, in light of declining COVID-19 rates. This announcement follows a series of inspection...more

2/9/2022 / Food and Drug Administration (FDA) , FSVP , GAO , Inspections , Life Sciences , Manufacturers , Pharmaceutical Industry , Prescription Drugs

FDA Proposes Framework for Transitioning COVID-Related Medical Devices from EUA/Enforcement Discretion to Permanent Marketing...

In two draft companion guidance documents, the US Food and Drug Administration (FDA) establishes a proposed framework for transitioning medical devices currently marketed under emergency use authorization (EUA) or enforcement...more

1/19/2022 / Coronavirus/COVID-19 , Emergency Use Authorization (EUA) , FDA Approval , Food and Drug Administration (FDA) , Life Sciences , Manufacturers , Medical Devices , Medical Supplies , Pharmaceutical Industry

Angela Silva

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