The FDA issued guidance March 4 to help the manufacturers of drugs and biologics report and implement common changes to glass vials and stoppers for approved sterile products administered parenterally. The guidance, which will be in effect through the COVID-19 pandemic, is intended to help manufacturers meet product demand or increase supply resilience during the public health emergency.
Australia eases substitution requirements
Australia passed a law allowing pharmacists to substitute a different drug when a patient's usual medicine has been declared to be in “serious scarcity,” the Therapeutic Goods Administration (TGA) said March 4. The law formalizes the Serious Shortages Substitution Notices (SSSNs) that have been used since last May and removes the need for an SSSN to be recognized by each state and territory before pharmacists can make the substitution. “Allowing pharmacists to substitute specific medicines without prior approval from the prescriber relieves pressure on doctors and helps patients get faster access to alternative medicines when there is a serious scarcity,” the TGA said.
Guidance details fast-tracking modified vaccines
New guidance from the ACCESS Consortium lays out details for fast-tracking modified COVID-19 vaccines for variants. Authorized COVID-19 vaccines that are modified in response to new variants won’t require a new approval or lengthy clinical studies, according to the guidance, but manufacturers will need robust evidence on the immune response. They also will be expected to provide evidence showing the modified vaccine is safe and of the expected quality. The consortium is a coalition of regulatory authorities from Australia, Canada, Singapore, Switzerland and the U.K.