Investigational Drug Information

1974 ◽  
Vol 8 (1) ◽  
pp. 25-26
Author(s):  
Larry M. Kleinman ◽  
Joseph A Tangrea ◽  
Joseph F. Gallelli

The drug information appearing in this column is for investigational drugs studied in clinical research protocols being pursued in the Clinical Center at the National Institutes of Health. As with all investigational drugs, the drugs reported in this column have a Notice of Claimed Investigational Exemption for a New Drug (IND) assigned to them by the Food and Drug Administration (F.D.A.).

1974 ◽  
Vol 8 (4) ◽  
pp. 182-183
Author(s):  
Larry M. Kleinman ◽  
Joseph A. Tangrea ◽  
Joseph F. Gallelli

The drug information appearing in this column is for investigational drugs studied in clinical research protocols being pursued in the Clinical Center at the National Institutes of Health. This same information, in the form of an “Investigational Drug Fact Sheet,” is distributed, prior to its use, to the dispensing pharmacist and the appropriate nursing units involved in the administration of the drug As with all investigational drugs, the drugs reported in this column have a Notice of Claimed Investigational Exemption for o New Drug (IND) assigned to them by the Food and Drug Administration (F.D.A.).


Author(s):  
Joshua M. Sharfstein

The emergence of AIDS in the early 1980s caused a profound crisis for federal health agencies, particularly the National Institutes of Health (NIH) and the U.S. Food and Drug Administration (FDA). Activists in ACT UP, charging that these agencies were failing patients with AIDS, initiated a series of escalating protests. NIH officials, led by Dr. Anthony Fauci, began to talk with the advocates and make major changes in the research process. However, over at the FDA, a protest involving the arrest of hundreds of AIDS activists undermined the agency’s public health image. Eventually, under a new commissioner, the FDA earned back the trust of activists.


2021 ◽  
Vol 14 (2) ◽  
pp. 145
Author(s):  
Othman Al Musaimi ◽  
Danah Al Shaer ◽  
Fernando Albericio ◽  
Beatriz de la Torre

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.


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