Quotes from the news wire:
Finally, the VRBPAC will be asked to discuss circumstances under which emergency use authorization could be considered for age groups within 6 months to 12 years and, in that context, data needed to support benefits of making COVID-19 vaccines available under emergency use authorization and safety data needed to assess risks.
The guidance also provides recommendations to test developers, such as considering the potential for future viral genetic mutations when designing their test, and conducting their own routine monitoring to evaluate the potential impact of new and emerging viral genetic mutations, which may be the basis of viral variants, on the performance for molecular, antigen and serology SARS-CoV-2 tests.
Based on the FDA's review of the totality of the scientific evidence available, the agency determined that it is reasonable to believe that bamlanivimab may be effective in treating non-hospitalized patients with mild or moderate Covid-19, and, when used to treat Covid-19 for the authorized population, the known and potential benefits outweigh the known and potential risks for the drug. There are no adequate, approved and available alternative treatments to bamlanivimab for the authorized population.
Manufacturers' failure to immediately recall all potentially affected products is placing consumers in danger of methanol poisoning, a warning letter has been issued to Eskbiochem S.A. de C.V. for distributing product with undeclared methanol, unapproved claims -- including incorrectly stating The FDA approval — and improper manufacturing practices.
We are continuing to adapt our approach based on real-world experience and data and so, as The FDA has authorized more antibody tests and validation data have become available, including through the capability at National Cancer Institute, the careful balancing of risks and benefits has shifted from where The FDA was in mid-March.
A Priority Review designation will direct overall attention and resources to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.
Liquid nitrogen, although non-toxic, can cause severe damage to skin and internal organs if mishandled or accidently ingested due to the extremely low temperatures it can maintain, inhaling the vapor released by a food or drink prepared by adding liquid nitrogen immediately before consumption may also cause breathing difficulty, especially among individuals with asthma.
All of the information to date suggests that women with breast implants have a very low but increased risk of developing ALCL compared to women who do not have breast implants, most cases of breast implant-associated ALCL are treated by removal of the implant and the capsule surrounding the implant and some cases have been treated by chemotherapy and radiation.
The two contraindications help to clarify the narrow population of patients in which laparoscopic power morcellation may be an appropriate therapeutic option, for example, some younger women who are interested in maintaining their ability to have children or wish to keep their uterus intact after being informed of the risks may be candidates for this procedure.