Planning a meeting at the FDA White Oak Campus? Download our multi-page Guide to FDA White Oak now and be prepared.
Planning a meeting at the FDA White Oak Campus? Download our multi-page Guide to FDA White Oak now and be prepared!
Meetings the FDA White Oak Campus can be intimidating – take away some of the stress by reviewing our Guide to the FDA’s White Oak Campus. Be prepared for this unique facility with the following information:
…and much more!
Planning for an FDA meeting, especially and Advisory Committee meeting, is scary enough! Be the star of your team and know the ins and outs of the campus before you even get there!
Do you have any favorite locations to stay or eat near the White Oak Campus? Share them with ISS here by commenting on this blog post – we’d love to hear from you!
Over the past few years, the number of ex-US manufacturers submitting a Class II exempt 510k device registration has increased substantially. For companies with medical devices that are approved and successful in a foreign market, the logical next step is to introduce their product into the US, which has one of the most lucrative healthcare markets in the world. Read more
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One of the main challenges our clients face is determining which regulatory pathway is best for their products. For example, what if an OTC product has a Monograph active ingredient but that ingredient is present at a different amount than the permitted amount? Or what if the label claims a novel indication not specified in a Monograph? If you are debating pursuit of either regulatory pathway for your OTC drug, it is critical to consider cost, timeline, and label claims to ensure your products has a unique stance in today’s market. Read more
US distributors and agents trying to import rapid antibody tests for coronavirus face a number of obstacles. The good news is that FDA has opened up the Emergency Use Authorization (EUA) program to include SARS-CoV-2 (the virus) and COVID-19 (the disease), expediting time to market. Read more
The journey to scientific and commercial success is often complex and always critical, if you are looking for an expert partner to help steer you to confident solutions, contact us today
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