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Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act. Finally, the Orange Book lists patents that are purported to protect each drug. Patent listings and use codes are provided by the drug application owner, and the FDA is obliged to list them.
The book was distributed for free to all licensed medical doctors in America; only drugs which drug manufacturers paid to appear, appeared in the PDR, and no generic drugs were listed. The 71st Edition, published in 2017, was the final hardcover edition, weighed in at 4.6 pounds (2.1 kg) and contained information on over 1,000 drugs. [ 1 ]
May also contain results of various clinical trials (studies) and/or explanations of the medication's effect on various populations (e.g. children, women, etc.). Indications and Usage - uses (indications) for which the drug has been FDA-approved (e.g. migraines, seizures, high blood pressure).
“It is the FDA’s role to ensure that drugs are safe and effective,” Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research, said in a statement.
USP establishes documentary (written) and reference (physical) standards for medicines, food ingredients, dietary supplement products, and ingredients. These standards are used by regulatory agencies and manufacturers to help to ensure that these products are of the appropriate identity, as well as strength, quality, purity, and consistency.
Martindale contains information on drugs in clinical use worldwide, as well as selected investigational and veterinary drugs, herbal and complementary medicines, pharmaceutical excipients, vitamins and nutritional agents, vaccines, radiopharmaceuticals, contrast media and diagnostic agents, medicinal gases, drugs of abuse and recreational drugs ...
Global Medical Device Nomenclature (GMDN) is a system of internationally agreed generic descriptors used to identify all medical device products. This nomenclature is a naming system for products which include those used for the diagnosis, prevention, monitoring, treatment or alleviation of disease or injury in humans.
Philips, the medical equipment maker that is recalling ventilators due to use of parts containing a potentially hazardous foam, said on Sunday it is in dicussions with U.S. regulators after a new ...