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Safety Update: New Sorbitol-Containing IV Remsima Formulation
Key Points: A new liquid infusion formulation of Remsima (infliximab) has been introduced in Europe as a 100 mg and 350 mg concentrate for infusion. Unlike the original…
Open guideline →Unlocking Flexibility: FDA’s 2025 Guidance on pH Adjuster Waivers for Complex Generics
Introduction The guidance addresses how generic-drug applicants (via an Abbreviated New Drug Application, ANDA) may request a waiver under 21 CFR 314.99(b) of the requirement in…
Open guideline →How to Prepare a Pre-Request for Designation (Pre-RFD)
Introduction The FDA’s guidance “How to Prepare a Pre-Request for Designation (Pre-RFD)” provides structured recommendations for sponsors seeking preliminary feedback from the Office of Combination Products…
Open guideline →Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Development of Therapeutic Protein Biosimilars: Comparative Analytical…
Open guideline →Development of Non-Opioid Analgesics for Chronic Pain
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Non-Opioid Analgesics for Chronic Pain.”…
Open guideline →Disseminated Coccidioidomycosis: Developing Drugs for Treatment
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Disseminated Coccidioidomycosis: Developing Drugs for Treatment.” The…
Open guideline →Erosive Esophagitis: Developing Drugs for Treatment
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled “Erosive Esophagitis: Developing Drugs for Treatment.”…
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