COVID-19 vaccines have now been approved for a few weeks, and nearly 2 million people in the United States have...
Catherine Milford
FDA Guidance Documents
If you are in the Life Sciences Industry you have heard of FDA Guidance Documents, and specifically, if you are in a...
FDA Approved Options for Uterine Fibroids
Uterine fibroids are a diagnosis that many women receive every day, however, it is a diagnosis that women often never...
The Difference Between Intended Use, Indications for Use, and Instructions for Use
No matter what your product is, at some point in your regulatory journey you will need to appropriately determine your...
The FDA’s Role in the HIV/AIDS Crisis Timeline
December is HIV/AIDS Awareness Month, and given the state of our current global pandemic, now is a great time to look...
Mammography and the FDA
If you have ever wondered exactly what role the FDA has in mammography and breast cancer screening, you are not alone....
Developing Clinical Trials for Your Intended User
For the past few decades, the FDA has been attempting to increase the diversity of individuals participating in...
FDA Guidance on the Treatment of Opioid Use Disorder
While COVID-19 has been the primary focus for most of us this past year, many of the health crises that were a problem...
Are Homeopathic Drugs a Thing of the Past?
Homeopathic medicines have been around since the 1700s, and the premise behind them has not changed much in the past...
The FDA Pathway to Generic Drugs
It is no secret that brand-name drugs in America are often expensive. Luckily, for the many American’s who are not...
The Importance of Packaging & Labeling Regulations
Few people outside of the industry know how big of a role the FDA has in product labeling and packaging. Every product...
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