The Canadian government announced a new measure to block bulk exports of certain prescription drugs if doing so would result in a drug shortage. The policy took effect Friday ahead of a Trump administration rule that would permit US wholesalers or pharmacists to import some prescription drugs in bulk from Canada.
The CDC's Advisory Committee for Immunization Practices is set to hold an emergency meeting Tuesday to vote on who should receive the COVID-19 vaccine first, once one is authorized by the FDA, and the CDC has already recommended that the first group include front-line health workers, support personnel, and residents of long-term-care facilities and nursing homes. HHS Secretary Alex Azar, however, said the government won't wait for ACIP's recommendations before shipping the initial doses, which is expected to happen within 24 hours of FDA authorization, and state governors will have the final say on who will get the first shots.
President-elect Joe Biden will let health experts, particularly the CDC, decide who will be prioritized to receive the first available COVID-19 vaccines authorized by the FDA, according to Celine Gounder, a member of his coronavirus advisory board. The CDC's Advisory Committee for Immunization Practices is tasked with recommending which high-risk groups will be given the vaccine first.
The FDA has released a final guidance detailing how complex generic developers can request and schedule formal meetings with the FDA as part of the abbreviated new drug application process. A second finalized guidance explains the details of the FDA qualification process for drug development tools.
Dole Fresh Vegetables has issued a 15-state recall on two products on concerns about potential E. coli contamination, according to the FDA. The voluntary recall covers the three-pack of Dole Romaine Heart and Wild Harvest Romaine Hearts, with harvest dates between Oct. 23 and Oct. 26.
Moderna has finalized its deal with the European Commission to initially supply 80 million doses of mRNA-1273, its experimental COVID-19 vaccine candidate. The deal includes an option to purchase an additional 160 million doses of the vaccine.
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