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Drug and Device February 2024

Drug and Device December 2023

With the requirement for Cosmetic Responsible Persons to report Serious Adverse Events to FDA beginning 29 December 2023, the agency has recommended using the current Form 3500A that is downloadable and fillable at MedWatch: The FDA Safety Information and Adverse...
Drug and Device February 2024

Drug and Device November 2023

Reminder that 31 December is the deadline for submitting your drug registration renewal, medical device establishment registration renewal and drug listing certification. If NDC listing blanket certification is not submitted, each individual SPL file will need to be...
Drug and Device February 2024

Drug and Device October 2023

The FDA published a new Guidance Document – Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications which articulates the agency’s evolving policy which has grown from the Pandemic era use of alternative tools in evaluating...
Drug and Device February 2024

Drug and Device September 2023

Reminder that FY2024 GDUFA payments are due 2 October 2023. The FDA does allow a 20 calendar day grace period, after which arrears lists will be published with the names of companies that have failed to make payment. Failure to pay required user fees by this deadline...