by Katrina Rogers | Mar 14, 2019 | Uncategorized
In Drug Development CDER published a survey article in February 2019 giving a capsule description of the application of Physiologically Based Pharmacokinetic Modeling (PBPM) in modern drug development. The article presents one of the nicest visuals for PBPM I’ve seen...
by Katrina Rogers | Mar 12, 2019 | Uncategorized
Guidance for Development of Anti-Drug Antibody TestsA fairly common event with therapeutic proteins is the generation of immune responses to the therapy or related proteins by the patient’s immune system. These immune responses have the potential to affect product...
by Katrina Rogers | Mar 10, 2019 | Uncategorized
The announcement on March 5th (in a staff letter which was shared on Twitter) that Scott Gottlieb, Commissioner of the FDA, would resign at the end of the month has created considerable speculation in the press. Along with questions about why (Dr. Gottlieb gave family...
by Katrina Rogers | Mar 7, 2019 | Uncategorized
Not all class I or II medical devices are required to undergo a premarket notification process with the FDA. Additionally, certain preamendment unclassified devices are considered to be sufficiently well understood that they, too, do not require premarket...
by Katrina Rogers | Mar 5, 2019 | Uncategorized
Humanitarian Device ExemptionA rare disease is defined in the Orphan Drug Act (ODA) of 1984 as a disease or condition that affects fewer than 200,000 people in the United. Because so few patients are affected, it can be difficult to gather enough clinical evidence for...
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