Newsletter - June 1, 2023
FDA Returns to In-Person Meetings Starting 12 June
After a hiatus of more than 3 years, the face-to-face (FTF) meetings between FDA and industry applicants will start in about 2 weeks. However, these meetings will not be like the widely attended meetings of the pre-pandemic years, but for selective types of discussions and on a hybrid format. Read More
FDA to Require New Patient-Friendly Medication Guides For all Drugs
Patients cannot read the fine print, called package insert (PI), accompanying their prescription drugs, leading to medication errors which in turn results in treatment failures and other serious consequences for the patients. To address that, FDA is proposing a new rule to require simplified drug information...Read More
FDA Returns to In-Person Meetings Starting 12 June
After a hiatus of more than 3 years, the face-to-face (FTF) meetings between FDA and industry applicants will start in about 2 weeks. However, these meetings will not be like the widely attended meetings of the pre-pandemic years, but for selective types of discussions and on a hybrid format. Read More
FDA to Require New Patient-Friendly Medication Guides For all Drugs
Patients cannot read the fine print, called package insert (PI), accompanying their prescription drugs, leading to medication errors which in turn results in treatment failures and other serious consequences for the patients. To address that, FDA is proposing a new rule to require simplified drug information...Read More
