Patrizia Cavazzoni | |
---|---|
Director of the Center for Drug Evaluation and Research [1] | |
Assumed office April 12, 2021 Acting: May 2020 – April 2021 | |
Preceded by | Janet Woodcock |
Acting Principal Deputy Commissioner of Food and Drugs [2] | |
In office January 2019 –February 2019 | |
Succeeded by | Amy Abernethy |
Deputy Center Director for Operations of the FDA Center for Drug Evaluation and Research | |
In office January 2018 –May 2020 | |
Personal details | |
Education | McGill University (MD) [2] |
Patrizia Cavazzoni is the director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER). Prior to this position she worked at Pfizer and had been a psychiatrist
Cavazzoni earned her medical degree from McGill University and subsequently was a fellow at the University of Ottawa. [2] She then joined the University of Ottawa as an assistant professor before moving to the pharmaceutical industry, [3] where she worked at Pfizer. [4]
She moved to the U.S. Food and Drug Administration in 2018,and was named acting director of the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research in 2020 [5] [6] and director in 2021. [4] During the COVID-19 pandemic,Cavazzoni has spoken publicly about the need for science to guide policies [7] and about the future of the Center for Drug Evaluation and Research after the COVID-19 pandemic. [8] She also noted that she would hand Donald Trump a blank sheet of paper if asked to submit a list of workers who should not receive due process protections. [9]
While she worked at the Royal Ottawa Hospital,Cavazzoni examined the link between genetics and personality,and the chemicals implicated in brain chemistry. [10] She further examined the connections between diabetes and patients receiving antipsychotic medications. [11]
Cavazzoni received the American College of Psychiatrists's Laughlin Fellowship. [2] [ when? ]
Antipsychotics, also known as neuroleptics, are a class of psychotropic medication primarily used to manage psychosis, principally in schizophrenia but also in a range of other psychotic disorders. They are also the mainstay together with mood stabilizers in the treatment of bipolar disorder.
The atypical antipsychotics (AAP), also known as second generation antipsychotics (SGAs) and serotonin–dopamine antagonists (SDAs), are a group of antipsychotic drugs largely introduced after the 1970s and used to treat psychiatric conditions. Some atypical antipsychotics have received regulatory approval for schizophrenia, bipolar disorder, irritability in autism, and as an adjunct in major depressive disorder.
Ziprasidone, sold under the brand name Geodon among others, is an atypical antipsychotic used to treat schizophrenia and bipolar disorder. It may be used by mouth and by injection into a muscle (IM). The IM form may be used for acute agitation in people with schizophrenia.
Olanzapine is an atypical antipsychotic primarily used to treat schizophrenia and bipolar disorder. For schizophrenia, it can be used for both new-onset disease and long-term maintenance. It is taken by mouth or by injection into a muscle.
Metformin, sold under the brand name Glucophage, among others, is the main first-line medication for the treatment of type 2 diabetes, particularly in people who are overweight. It is also used in the treatment of polycystic ovary syndrome. It is not associated with weight gain and is taken by mouth. It is sometimes used as an off-label adjunct to lessen the risk of metabolic syndrome in people who take antipsychotics.
Troglitazone is an antidiabetic and anti-inflammatory drug, and a member of the drug class of the thiazolidinediones. It was prescribed for people with diabetes mellitus type 2.
Tiotixene, or thiothixene, sold under the brand name Navane among others, is a typical antipsychotic of the thioxanthene class which is related to chlorprothixene and is used in the treatment of psychoses like schizophrenia and bipolar mania. It was introduced in the United States in 1967 by Pfizer.
In the United States, a boxed warning is a type of warning that appears on the package insert for certain prescription drugs, so called because the U.S. Food and Drug Administration specifies that it is formatted with a 'box' or border around the text. The FDA can require a pharmaceutical company to place a boxed warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.
Alkermes plc is a pharmaceutical company that focuses on central nervous system (CNS) diseases like schizophrenia, bipolar disorder, depression, addiction and multiple sclerosis. The company was founded in 1987 by Michael Wall. In September 2011 Alkermes, Inc. merged with Elan Drug Technologies (EDT), the former drug formulation and manufacturing division of Élan Corporation, plc. The company is headquartered in Dublin, and has an R&D center in Waltham, Massachusetts, and manufacturing facilities in Athlone, Ireland, and Wilmington, Ohio.
Inhalable insulin is a powdered form of insulin, delivered with an inhaler into the lungs where it is absorbed. In general inhaled insulins have been more rapidly absorbed than subcutaneous injected insulin, with faster peak concentration in serum and more rapid metabolism.
The Center for Drug Evaluation and Research is a division of the U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also legally considered drugs, but they are covered by the Center for Biologics Evaluation and Research. The center reviews applications for brand name, generic, and over the counter pharmaceuticals, manages US current Good Manufacturing Practice (cGMP) regulations for pharmaceutical manufacturing, determines which medications require a medical prescription, monitors advertising of approved medications, and collects and analyzes safety data about pharmaceuticals that are already on the market.
Olanzapine/fluoxetine is a fixed-dose combination medication containing olanzapine (Zyprexa), an atypical antipsychotic, and fluoxetine (Prozac), a selective serotonin reuptake inhibitor (SSRI). Olanzapine/fluoxetine is primarily used to treat the depressive episodes of bipolar I disorder as well as treatment-resistant depression.
Dirlotapide is a drug used to treat obesity in dogs. It is manufactured by Pfizer and Zoetis and marketed under the brand name Slentrol.
A dry-powder inhaler (DPI) is a device that delivers medication to the lungs in the form of a dry powder. DPIs are commonly used to treat respiratory diseases such as asthma, bronchitis, emphysema and COPD although DPIs have also been used in the treatment of diabetes mellitus.
Lurasidone, sold under the trade name Latuda among others, is an antipsychotic medication used to treat schizophrenia and bipolar disorder. It is taken by mouth.
An orexigenic, or appetite stimulant, is a drug, hormone, or compound that increases appetite and may induce hyperphagia. This can be a medication or a naturally occurring neuropeptide hormone, such as ghrelin, orexin or neuropeptide Y, which increases hunger and therefore enhances food consumption. Usually appetite enhancement is considered an undesirable side effect of certain drugs as it leads to unwanted weight gain, but sometimes it can be beneficial and a drug may be prescribed solely for this purpose, especially when the patient is suffering from severe appetite loss or muscle wasting due to cystic fibrosis, anorexia, old age, cancer or AIDS. There are several widely used drugs which can cause a boost in appetite, including tricyclic antidepressants (TCAs), tetracyclic antidepressants, natural or synthetic cannabinoids, first-generation antihistamines, most antipsychotics and many steroid hormones. In the United States, no hormone or drug has currently been approved by the FDA specifically as an orexigenic, with the exception of Dronabinol, which received approval for HIV/AIDS-induced anorexia only.
Samidorphan, is an opioid antagonist which in the form of olanzapine/samidorphan is used in the treatment of schizophrenia and bipolar disorder. Samidorphan reduces the weight gain associated with olanzapine. Samidorphan is taken by mouth.
Janet Woodcock is an American physician and former Acting Commissioner of the U.S. Food and Drug Administration (FDA). She joined the FDA in 1986, and has held a number of senior leadership positions there, including terms as the Director of Center for Drug Evaluation and Research (CDER) from 1994 to 2004 and 2007 to 2021.
Olanzapine/samidorphan (OLZ/SAM), sold under the brand name Lybalvi, is a fixed-dose combination medication for the treatment of schizophrenia and bipolar I disorder. It contains olanzapine, an atypical antipsychotic, and samidorphan, an opioid antagonist. Samidorphan reduces the weight gain associated with olanzapine while still allowing olanzapine to exert its therapeutic effect. The formulation was approved for medical use in the United States in May 2021.