FDA approves first commercial product for peanut allergy prevention

The approach towards preventing peanut allergies has changed dramatically in recent years. Now the US Food and Drug Administration has approved the first commercial product, called Hello, Peanut!, to help inform the public that early peanut introduction and regular consumption can reduce the risk of peanut allergy in young children. The Hello, Peanut! introduction kit […]

FDA Breaks New Ground With First Approved Gene Therapy for Cancer

When oncologist Dr. Carl June heard the Food and Drug Administration’s decision to bring the first gene therapy to market in the US, he pinched himself, hard. “It was so improbable that this would ever be a commercially approved therapy,” he said, voice breaking with emotion. June was referring to a revolutionary cancer therapy that […]

FDA advisors give a thumbs-up to GlaxoSmithKline’s shingles vaccine

GlaxoSmithKline’s shingles Shingrix vaccine received an unanimous vote of support by a Food and Drug Administration advisory committee Wednesday on safety and effectiveness to be used in adults 50 and older. A decision by the FDA to commercialize Shingrix is expected later this year. The agency usually follows the recommendations of its advisory panels. GSK […]

New FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods and adherence to them

The U.S. Food and Drug Administration (FDA) is in the process of finalising food safety rules. A major part of these rules is devoted to the ways by which to ensure scientific and safe transportation and logistics food transportation. The FDA is required to establish rules for that improve, audit and enforce new rules relating […]

Making sense of the FDA’s GMP and Regulatory Expectations for Early IND Products

The FDA’s recent guidance documents covering GMP requirements for Phase I products have considerably reduced some of the complexities early phase products face. These guidance documents are in addition to those that cover the CMC sections for IND submissions at Phase I. Although these new guidelines appear to remove the need to follow GMPs for […]

FDA Guideline on Process Validation

FDA Guideline on Process Validation. Process Validation (PV), as defined by the FDA, has undergone a change from the past 25 years or so. The meaning of PV is what the FDA assigns to it. So, any understanding of PV has to be tied to FDA’s guidelines which offer a definition of the term, as […]