Each month, Camargo’s “In the News” series highlights important changes and advancements in the regulatory and development space and explores how those changes could impact your program. Remote Document Review Leads to CRL: Be Careful What You Wish for? The FDA’s halt of onsite inspections
Dogma says that a compound used for a nutrition, such as a vitamin, cannot be a drug. Such dogma prevents the development of many good drugs. The FDA just approved vitamin C – ascorbic acid as a drug. Read on to learn how this came
As the 505(b)(2) expert, Camargo is exposed to many projects in which Sponsors have attempted to leverage the 505(b)(2) pathway as a way to utilize information obtained from studies not conducted by or for the Sponsor. For the 505(b)(2) pathway, the strategic leveraging of
Few things can be more damaging to a pharmaceutical company than the refusal by the Food and Drug Administration (FDA) to review their New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). When a company submits their application for authorization to market a new
Desmopressin (DDAVP®; Ferring Pharmaceuticals Inc) was approved in the US in 1978. DDAVP is currently approved to treat central diabetes insipidus, hemophilia A, type 1 von Willebrand’s disease, nocturnal enuresis (bedwetting) in children, and as a diagnostic test to measure renal concentrating abilities. Desmopressin is
On May 27, 2016, AstraZeneca announced they received a Complete Response Letter (CRL) from the FDA for their sodium zirconium cyclosilicate (ZS-9) New Drug Application (NDA) (reference link). This hyperkalemia drug was developed by ZS Pharma and was generally expected to receive FDA approval when