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FDA
FDA Releases Draft Guidance on New MAT Opioid Use Disorder Treatments
On August 6, 2018, the United States Food and Drug Administration (FDA) released draft guidance, Opioid Use Disorder: Endpoints…
FDA Hits Baxter with Warning Letter Over Claris Acquisition
Almost one year to the day Baxter acquired Claris Injectables, the United States Food and Drug Administration (FDA) sent a warning…
FDA Announces Two New Quality Metrics Programs
Earlier this year, the U.S. Food and Drug Administration (FDA) announced two new voluntary quality programs — the Quality Metrics…
Pfizer is Subject of FDA’s Second Untitled Letter of 2018
In June 2018, the United States Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) sent its second…
Congress and FDA address Over the Counter Drugs
On the evening of July 16, the House passed a sweeping over-the-counter (OTC) drug regulation reform bill, bringing the first…
FDA Releases Draft Guidance on Indications and Usage Labeling Sections
On July 9, 2018, the United States Food and Drug Administration (FDA) issued draft guidance entitled, “Indications and Usage…
FDA Releases Final Guidance on Medical Product Communications and Labeling
Recently, the United States Food and Drug Administration (FDA) released “Medical Product Communications That Are Consistent With…
FDA Publishes Draft Guidance on Expanding 510(k) Pathway
A draft guidance recently issued by the United States Food and Drug Administration (FDA) sets the stage for how an existing 510(k)…
FDA Prepares for OND Modernization
On Friday, May 4, 2018, United States Food and Drug Administration (FDA) Commissioner Scott Gottlieb, MD, discussed plans to…
FDA Final Guidance: Drug and Device Manufacturer Communications with…
FDA recently announced the availability of an important guidance for industry. The document, “Drug and Device Manufacturer…