by Katrina Rogers | Nov 27, 2018 | Uncategorized
Understanding How We Make Decisions Many people ask me for professional advice on making a decision, to which question there is seldom a short answer. To prepare for such questions, I recommend reading widely about the science behind our decision-making processes....
by Katrina Rogers | Nov 25, 2018 | Uncategorized
The Orange Book is the common name for the FDA publication “Approved Drug Products with Therapeutic Equivalence Evaluations”. This reference work contains lists of drug products approved by the FDA, and its purpose is to enable providers and patients find substitute...
by Katrina Rogers | Nov 22, 2018 | Uncategorized
CDRH has published a list of guidance documents that the division intends to publish or review in FY2019. There are 3 separate parts to the list:The “A list”, guidance documents that the division intends to publish,The “B list”, guidance that will be published as...
by Katrina Rogers | Nov 20, 2018 | Uncategorized
– what has and hasn’t been reviewed and approved Genetic testing to enhance patient outcomes is a hot topic in the news this year, and the FDA plays a role in reviewing and approving such tests for use. Some of the claims made by providers have not been reviewed by...
by Katrina Rogers | Nov 18, 2018 | Uncategorized
– draft guidance comment period ends 15DEC2018Interested parties have about a month to comment on the draft guidance for those planning to use minimal residual disease (MRD) as a biomarker in oncology clinical trials for treatment of blood diseases. Released in...
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