Quotes from the news wire:
In order to safely prescribe Paxlovid, the potential for DDIs needs to be considered by all prescribers, both to take actions to manage DDIs and also to determine whether Paxlovid is an appropriate treatment choice for each individual patient when factoring in the risks of serious adverse reactions due to DDIs.
This simplification of vaccine composition should reduce complexity, decrease vaccine administration errors due to the complexity of the number of different vial presentations, and potentially increase vaccine compliance by allowing clearer communication.
Found on CNN 8 months ago
Drug shortages can occur for many reasons, including manufacturing and quality problems, delays and discontinuations, manufacturers provide FDA [with] most drug shortage information, and the agency works closely with them to prevent or reduce the impact of shortages.
Found on FOX News 10 months ago
In Trial AA-1, 22% of the 184 patients who received 2 milligrams of Olumiant and 35% of the 281 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 5% of the 189 patients who received a placebo. In Trial AA-2, 17% of the 156 patients who received 2 milligrams of Olumiant and 32% of the 234 patients who received 4 milligrams of Olumiant achieved adequate scalp hair coverage, compared to 3% of the 156 patients who received a placebo.
The main outcome measured in the trial was whether a patient was hospitalized for any COVID-19 related reason or died from any reason within 28 days of treatment. Overall, two of 279 patients who received Veklury (0.7%) required COVID-19 related hospitalization compared to 15 of 283 patients who received a placebo (5.3%). There were no deaths in either group.
Additionally, peer-reviewed data from multiple laboratories indicate that a booster dose of the Pfizer-BioNTech COVID-19 Vaccine greatly improves an individual’s antibody response to be able to counter the omicron variant, authorizing booster vaccination to take place at five months rather than six months may therefore provide better protection sooner for individuals against the highly transmissible omicron variant.
RADx recently performed preliminary studies evaluating the performance of some antigen tests using patient samples containing live virus, which represents the best way to evaluate true test performance in the short-term, early data suggests that antigen tests do detect the omicron variant but may have reduced sensitivity.
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.
Found on FOX News 3 years ago
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.
Nothing is of greater concern to Kimberly-Clark than the quality of our products and the well-being of the consumers who use them.
Found on CNN 7 years ago
The drug works by reducing the number of receptors on the liver that remove LDL cholesterol from the blood. By blocking PCSK9's ability to work, more receptors are available to get rid of LDL cholesterol from the blood and, as a result, lower LDL cholesterol levels.
Found on CNN 8 years ago
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.
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