USA – FDA issues guidance on resuming or initiating BE studies amid pandemic

New guidance from the US Food and Drug Administration (FDA) issued on Friday provides recommendations for resuming or initiating bioequivalence (BE) studies for generic...

USA – COVID-19: Potency Assay Considerations for Monoclonal Antibodies and Other Therapeutic Proteins Targeting...

FDA plays a critical role in protecting the United States from threats such as emerging infectious diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic....
Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs

USA – HHS pushes through last-minute policies impacting FDA

With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that...
New guidance on biologics affects authorized generics

USA – FDA lays out 2021 regulatory science areas of focus

Three strategic initiatives form the backbone of the regulatory science areas of focus for the US Food and Drug Administration in 2021, according to...

USA – FDA offers first thoughts on neurodegenerative disease gene therapies

The US Food and Drug Administration (FDA) has issued draft guidance on the development, testing, and trial design for human gene therapies for neurodegenerative...
Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19) : Guidance

USA – What happened with FDA’s OTC monograph user fee notice?

Just before the New Year, the US Food and Drug Administration (FDA) published a notice in the Federal Register announcing the fee rates it will collect for its...

USA – Severe reactions to COVID-19 vaccines very rare

A severe allergic reaction to the COVID-19 vaccine is "exceedingly rare," reported by 21 of 1.9 million people in the United States who have received the...

USA – ‘N of 1’ therapies addressed in draft FDA guidance

Recognizing the pace at which drug developers are moving ever further into individualized medicine, the US Food and Drug Administration (FDA) has issued a...

USA – Slaoui: Vaccines should control new coronavirus variant

Moncef Slaoui, head of the White House's Operation Warpspeed, said the new coronavirus variant "should be under control" with the vaccines.  "This virus...

USA – FDA guidance targets REMS document e-submission

The US Food and Drug Administration (FDA) has issued final guidance on the electronic submission of documents related to the Risk Evaluation and Mitigation...

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