Pearls of Wisdom
What is Cold Chain and Why Does it Matter for My Products?
Drugs, like any other molecule, are affected by exposure to temperature extremes. Hot and cold can both be the enemy of your product’s quality. How much of a risk is this in the ordinary course of events? Let’s think about how a product moves through the...
New recommendations to clarify shared system REMS and prevent delay entry of generic drugs
The Food and Drug (FDA) Commissioner Scott Gottlieb released a statementon new policies aimed to prevent the practice of using certain agency requirements to block timely generic drug entry. The release came two weeks after the FDA called outbrand...
Experienced biopharmaceutical and diagnostic leader joins Pearl Pathways
Pearl Pathways announces the hiring of Nancy Kant as Clinical Services Advisor to support biopharmaceutical and diagnostic life science companies. A skilled biologist, Kant brings over 35 years of experience in the pharmaceutical and diagnostics industries...
‘Right-to-try’ bill passes Congress: What you need to know
On May 22nd, the House voted to approve a version of “right-to-try” legislation. The bill passed by a vote of 250-169. The bill is intended to help patients with life-threatening conditions, allowing them to access medicines that the Food and Drug...
New Draft Guidance on Maximal Usage Trials for OTC Drugs
On May 22, 2018, the US Food and Drug Administration (FDA) issued draft guidance for drug makers on maximal usage trials for the purpose of adding a topical active ingredient to an over-the-counter (OTC) drug monograph. A maximal usage trial is a...