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19 hours ago · 10 Things to Know about CDER’s Pharmaceutical Quality Functions. Pharmaceutical quality is about more than just the quality of the drug itself. It includes the manufacturing facilities and the ...
4 hours ago · The FDA will convene a panel of independent investigators on June 4 to determine whether to recommend the drug’s approval. Proponents of the new therapies also worry that the FDA will impose treatment protocols, such as requiring multiple trained clinicians to monitor a patient for extended periods, that will render them far too expensive for ...
1 day ago · The US Food and Drug Administration (FDA) has published a much-awaited draft guidance detailing how it plans to implement its new platform technology designation program. Drug sponsors can use platform technologies to manufacture more than one drug or biological product through a standardized production or manufacturing process, and the program is intended to provide predictability on how they ...
4 days ago · An adverse drug reaction (ADR) is an unwanted or harmful reaction experienced following the administration of a drug or combination of drugs under normal conditions of use and is suspected to be related to the drug. An ADR will usually require the drug to be discontinued or the dose reduced.
5 days ago · The FDA is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the ...
5 days ago · An antibiotic is a type of antimicrobial substance active against bacteria. It is the most important type of antibacterial agent for fighting bacterial infections, and antibiotic medications are widely used in the treatment and prevention of such infections. [1] [2] They may either kill or inhibit the growth of bacteria.
1 day ago · Lysergic acid diethylamide, commonly known as LSD (from German Lysergsäure-diethylamid ), and known colloquially as acid or lucy, is a potent psychedelic drug. [12] Effects typically include intensified thoughts, emotions, and sensory perception. [13] At sufficiently high dosages, LSD manifests primarily mental, visual, and auditory ...
