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The Indonesian Food and Drug Authority (Indonesian: Badan Pengawas Obat dan Makanan, lit. 'Food and Drug Supervisory Agency'), Badan POM/BPOM, or Indonesian FDA is a government agency of Indonesia responsible for protecting public health through the control and supervision of prescription and over-the-counter pharmaceutical drugs (medication), vaccines, biopharmaceuticals, dietary supplements ...
Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests:
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...
The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug across state lines (usually to clinical investigators) before a marketing application for the drug has been approved.
Food and Drug Administration v. Alliance for Hippocratic Medicine, 602 U.S. 367 (2024), was a United States Supreme Court case to challenge the U.S. Food and Drug Administration (FDA)'s approval of mifepristone, a drug frequently used in medical abortion procedures.
The drug works by inhibiting reverse transcriptase, the enzyme that copies HIV RNA into new viral DNA. By interfering with this process, which is central to the replication of HIV, emtricitabine can help to lower the amount of HIV, or " viral load ", in a patient's body and can indirectly increase the number of immune system cells (namely T ...
Once bound to a β 2 receptor, an olodaterol molecule stays there for hours — its dissociation half-life is 17.8 hours — which allows for once-a-day administration of the drug [4] like with indacaterol. Other related compounds generally have a shorter duration of action and have to be administered twice daily (e.g., formoterol, salmeterol).
Like ritonavir, delavirdine is an inhibitor of cytochrome P450 isozyme CYP3A4, and interacts with many medications.It should not be administered with a wide range of drugs, including amprenavir, fosamprenavir, simvastatin, lovastatin, rifampin, rifabutin, rifapentine, St John's wort, midazolam, triazolam, ergot medications, and several medications for acid reflux.