Regulatory Perspectives: One Academic Viewpoint From the United States

The development of new drugs to treat vascular dementia and other conditions in which cognitive impairment is due at least in part to vascular pathology will require future interaction among academic, industry, and government regulatory clinicians and scientists. This article offers the author's perspective on the positive involvement of the Food and Drug Administration in development of conceptual frameworks and practical approaches to treatment of conditions characterized by vascular burden of the brain.

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Anesthetic and Analgesic Drug Products Advisory Committee Activity and Decisions in the Opioid-crisis Era

Anesthesiology ◽

10.1097/aln.0000000000003485 ◽

2020 ◽

Vol 133 (4) ◽

pp. 740-749 ◽

Cited By ~ 2

Author(s):

Ronald S. Litman

Keyword(s):

United States ◽

Advisory Committee ◽

Drug Administration ◽

Drug Product ◽

Food And Drug Administration ◽

The United States ◽

New Drugs ◽

Analgesic Drug ◽

Drug Products ◽

United States Food

The United States Food and Drug Administration is tasked with ensuring the efficacy and safety of medications marketed in the United States. One of their primary responsibilities is to approve the entry of new drugs into the marketplace, based on the drug’s perceived benefit–risk relationship. The Anesthetic and Analgesic Drug Product Advisory Committee is composed of experts in anesthesiology, pain management, and biostatistics, as well as consumer and industry representatives, who meet several times annually to review new anesthetic-related drugs, those seeking new indications, and nearly every opioid-related application for approval. The following report describes noteworthy activities of this committee since 2017, as it has grappled, along with the Food and Drug Administration, to balance the benefit–risk relationships for individual patients along with the overarching public health implications of bringing additional opioids to market. All anesthesia advisory committee meetings since 2017 will be described, and six will be highlighted, each with representative considerations for potential new opioid formulations or local anesthetics.

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2018 FDA Tides Harvest

Pharmaceuticals ◽

10.3390/ph12020052 ◽

2019 ◽

Vol 12 (2) ◽

pp. 52 ◽

Cited By ~ 22

Author(s):

Danah Al Shaer ◽

Othman Al Musaimi ◽

Fernando Albericio ◽

Beatriz de la Torre

Keyword(s):

United States ◽

Drug Administration ◽

Mode Of Action ◽

Chemical Structure ◽

Food And Drug Administration ◽

The United States ◽

New Drugs ◽

Target Mode ◽

United States Food ◽

States Food

In 2018, the United States Food and Drug Administration (FDA) approved a total of 59 new drugs, three of them (5%) are TIDES (or also, -tides), two oligonucleotides and one peptide. Herein, the three TIDES approved are analyzed in terms of medical target, mode of action, chemical structure, and economics.

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2020: A Record Year for Drug Approvals

The Senior Care Pharmacist ◽

10.4140/tcp.n.2021.174 ◽

2021 ◽

Vol 36 (4) ◽

pp. 174-175

Author(s):

Nancy L. Losben

Keyword(s):

United States ◽

Drug Administration ◽

Generic Drugs ◽

Drug Evaluation ◽

Food And Drug Administration ◽

The United States ◽

New Drugs ◽

Novel Drugs ◽

United States Food ◽

States Food

In 2020 The United States Food and Drug Administration?s (FDA) Center for Drug Evaluation and Research (CDER) approved 53 novel drugs, five more than in 2019, but still an aggressive number when compared with 2015 when only 45 new drugs were released to the market. CDER, the largest department within the FDA, has robustly approved a rising number of generic drugs in the last several years, increasing their accessibility and reducing patient and payor costs.

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