FDA classifies inspections based on a company’s state of compliance as acceptable or unacceptable with respect to CGMP requirements: No action indicated (NAI) classification indicates a facility […]

Patients often receive several types of informational documents with their prescription medication. These documents are intended to help patients take their drugs safely and effectively, help […]

FDA is notifying consumers of certain products promoted for arthritis and pain management that have been found to contain hidden ingredients and may pose a significant […]

[4-17-2024] The Food and Drug Administration is advising consumers not to purchase or use Ossos-Sans, a product promoted and sold for pain on various websites, including https://alnaturaleshop.com, […]

Medication Safety Two-Year Medication Error Pharmacovigilance and Risk Management Fellowship provided by Butler University Fellowship dates: TBD, typical timeline shown below. Four months will be spent […]

When are user fees due? An application fee is due when the application is submitted to FDA. FDA issues invoices for annual program fees for the […]

On This Page Date: May 20 – 21, 2024 Day1: Mon, May 20 8:00 AM – 4:30 PM ET Day2: Tue, May 21 8:00 AM – […]

Number of core initial promotional campaign material reviews completed in the month Dictionary: “Launch” materials are the initial promotional materials that companies disseminate to healthcare professionals […]

On This Page Date: April 10 – 11, 2024 Day1: Wed, Apr 10 8:30 AM – 5:00 PM ET Day2: Thu, Apr 11 8:30 AM – […]