Medmarc Blog (blog.medmarc.com)
A Guide to FDA's Labeling Guidelines on Biosimilars and the Implications for Products Liability
The field of biopharmaceuticals has witnessed significant advancements in recent years, particularly in the realm of biosimilars. Biosimilars are biological products that are similar to an...
FDA Draft Guidance For Predetermined Change Control Plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML)-Enabled Device Software Functions
Since the publication of the Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan in 2021, interested parties have been awaiting guidance from...
The Modernization of Cosmetics Regulation Act of 2022
Cosmetic companies did not expect to be impacted so heavily by the 4155-page, 1.7 trillion-dollar omnibus spending bill enacted by Congress for this year. Within this bill is the Modernization...
FDA Proposes Two New Rules to Eliminate Contradictions with the HHS’ Common Rule
The US Food and Drug Administration (FDA) has long held rules governing clinical investigations and studies that support research and marketing applications. These regulations are stricter...
Three Years Since the Draft Guidance was Released, FDA Issues their Final Guidance Document on Clinical Decision Support Software
On September 28, 2022, FDA released their 26-page final guidance document titled, “Clinical Decision Support Software.” This much anticipated final guidance document aims to set out which types...
President Biden Signs Executive Order to Launch a National Biotechnology and Biomanufacturing Initiative
On Monday, September 12, 2022, President Joe Biden signed an Executive Order to launch a National Biotechnology and Biomanufacturing Initiative. The official White House correspondence emphasizes...
Comment Period Closes for FDA’s Draft Guidance Document, "Risk Management Plans to Mitigate the Potential for Drug Shortages"
The COVID-19 pandemic brought to light the fragility of the pharmaceutical supply chain and demonstrated that disruptions can lead to drug shortages. We have written extensively about the...