Search Results: test FDA

Are Pre-Approval and Pre-Licensure Inspections Limiting Approvals During COVID-19?

In this post, we discuss FDA’s conduct of inspections of manufacturing facilities for new drugs and biologics during the COVID-19 pandemic. These inspections, known as pre-approval and pre-licensure inspections (PAIs/PLIs, respectively), are performed to give FDA assurance that a manufacturing site named in a new drug or biologics license application…

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The Continuing Saga of Lab Developed Tests, Including for COVID-19 Testing

In August, the U.S. Department of Health & Human Services (HHS) announced that the FDA will not require premarket review of laboratory developed tests (LDTs), whether COVID-19 related or not, absent notice-and-comment rulemaking.  Labs may voluntarily seek a premarket approval, 510(k) clearance, or an emergency use authorization (EUA) for their…

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The Purple Book and The Orange Book - When do Patents Expire and Regulatory Exclusivities end for FDA Approved Products?

The Food and Drug Administration (FDA) maintains two searchable online databases for approved products: the Purple Book (approved licensed biological products) and the Orange Book (approved drug products). The Orange Book provides details about an approved drug product, including the patents covering the approved drug product and the expiration dates…

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FDA’s COVID-19 Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders

Developers of certain digital health devices for treating psychiatric disorders may be able to take advantage of an FDA enforcement policy, which remains in effect for the duration of the COVID-19 public health emergency.  The policy applies to certain prescription computerized behavioral therapy (CBT) devices for psychiatric disorders, digital health…

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Conduct of Clinical Trials During the COVID-19 Pandemic: Recommendations from FDA

As the COVID-19 pandemic unfolds, our drug, biologic, and medical device clients conducting or planning to conduct clinical trials may be faced with challenges related to quarantines, travel limitations, site closures or access restrictions, infection transmission concerns of site research personnel and study subjects, and supply chain interruptions. Nonetheless, it…

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Q&A on FDA’s Requirements Related to Financial Disclosure by Clinical Investigators

What financial arrangements between clinical trial sponsors and clinical investigators must be disclosed in a drug, biologic or device marketing application? In a marketing application, FDA requires that four types of financial arrangements be disclosed: (1) any financial arrangement between the sponsor and the investigator whereby the value of the…

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