FDA published notification on 6 guidance documents

 FDA released a number of final and draft guidance last Friday (2Jun2023):

Recently Posted Guidance Documents

• 6/22/2023 - Drug-Drug Interaction Assessment for Therapeutic Proteins Guidance for Industry: Guidance for Industry
• 6/5/2023 - Nonclinical Evaluation of the Immunotoxic Potential of Pharmaceuticals
• 6/2/2023 - Interstitial Cystitis/Bladder Pain Syndrome: Establishing Drug Development Programs for Treatment: Draft Guidance for Industry
• 6/2/2023 - Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program: Guidance for Industry and Food and Drug Administration Staff
• 6/1/2023 - Guidance for Industry: Action Level for Inorganic Arsenic in Apple Juice
• 6/1/2023 - Migraine: Developing Drugs for Preventive Treatment

Interesting is that the first two are dated for later in the month.

The first one will have a lot of interest due to the number of therapeutic proteins in drug development.  The second is of interest for those who would have to conduct the studies, as well as analyze the samples to determine if immune-suppression or -stimulation is occurring.