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 powder form, the new concentrate contains sorbitol (45 mg/mL)ema.europa.eu. Because patients with hereditary fructose intolerance (HFI) cannot safely metabolize sorbitol, this formulation must not be given to HFI patientsema.europa.eu. Even […]
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 21 CFR 314.94(a)(9)(iii) and (iv) that inactive ingredients (specifically pH adjusters) in a generic product be qualitatively (Q1) and quantitatively (Q2) the same as the Reference Listed Drug (RLD), […]
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 (OCP) on how their product should be classified (drug, device, biologic, or combination product) and to which FDA centre (e.g.,Although this is a U.S. FDA document, its lessons and […]
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 Assessment and Other Quality-Related Considerations.” This guidance describes the Agency’s recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic […]
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled “Development of Non-Opioid Analgesics for Chronic Pain.” This guidance is intended to assist sponsors in the development of non-opioid analgesics for the treatment of chronic pain. It describes FDA’s current recommendations regarding phase 3 trials for […]
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 purpose of this draft guidance is to assist sponsors in the clinical development of drugs for the treatment of disseminated coccidioidomycosis caused by Coccidioides species ( i.e., C. immitis […]
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.” The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for […]