National Institutes of Health, U.S. Food and Drug Administration, 15 Partners to Accelerate Development of Rare Disease Gene Therapies

2021 ◽  
Vol 32 (23-24) ◽  
pp. 1420-1422
Author(s):  
Alex Philippidis
Keyword(s):  
Rare Disease ◽  
Drug Administration ◽  
Disease Gene ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Gene Therapies ◽  
Accelerate Development

HIV

2018 ◽  
Author(s):  
Joshua M. Sharfstein
Keyword(s):  
Public Health ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Research Process ◽  
National Institutes Of Health ◽  
Health Agencies ◽  
Act Up ◽  
The U.S

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.

The Ethical Health Lawyer

2005 ◽  
Vol 33 (1) ◽  
pp. 160-162 ◽  
Author(s):  
Leslie Griffin
Keyword(s):  
Patient Safety ◽  
Side Effects ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Public Attention ◽  
Institutional Misconduct ◽  
Heart Attacks ◽  
The Public

“There's a new whistleblower in Washington,” according to CNN News. He is Food and Drug Administration scientist David Graham, who claims that the FDA failed to warn the public about certain drugs' dangerous side effects and pressured him to change his research's conclusion that the arthritis drug Vioxx caused heart attacks. Another Washington whistleblower, Dr. Jonathan Fishbein of the National Institutes of Health, alleged that he was fired because “he had raised concerns about sloppy practices that might endanger patient safety” in a study of the AIDS drug nevirapine.Graham and Fishbein thus joined the ranks of whistleblowers who have gained some prominence in recent years for their reporting of corporate or institutional misconduct. The best-known whistleblowers—the FBI's Coleen Rowley, Enron's Sherron Watkins, and WorldCom's Cynthia Cooper, who together received Time magazine's Whistleblower Person of the Year Award in 20024 - focused public attention on the reform of corporate accounting and legal practices.

Investigational Drug Information

1974 ◽  
Vol 8 (4) ◽  
pp. 182-183
Author(s):  
Larry M. Kleinman ◽  
Joseph A. Tangrea ◽  
Joseph F. Gallelli
Keyword(s):  
Clinical Research ◽  
Drug Administration ◽  
Drug Information ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Investigational Drug ◽  
Fact Sheet ◽  
Research Protocols ◽  
Clinical Center ◽  
Investigational Drugs

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.).

scholarly journals Diabetes Technology Society Report on the FDA Digital Health Software Precertification Program Meeting

2018 ◽  
Vol 13 (1) ◽  
pp. 128-139 ◽  
Author(s):  
Fraya King ◽  
David C. Klonoff ◽  
David Ahn ◽  
Saleh Adi ◽  
Erika Gebel Berg ◽  
...  
Keyword(s):  
Behavioral Health ◽  
Drug Administration ◽  
Real World ◽  
Review Process ◽  
Digital Health ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Society Report ◽  
Diabetes Technology ◽  
The Us

Diabetes Technology Society (DTS) convened a meeting about the US Food and Drug Administration (FDA) Digital Health Software Precertification Program on August 28, 2018. Forty-eight attendees participated from clinical and academic endocrinology (both adult and pediatric), nursing, behavioral health, engineering, and law, as well as representatives of FDA, National Institutes of Health (NIH), National Telecommunications and Information Administration (NTIA), and industry. The meeting was intended to provide ideas to FDA about their plan to launch a Digital Health Software Precertification Program. Attendees discussed the four components of the plan: (1) excellence appraisal and certification, (2) review pathway determination, (3) streamlined premarket review process, and (4) real-world performance. The format included (1) introductory remarks, (2) a program overview presentation from FDA, (3) roundtable working sessions focused on each of the Software Precertification Program’s four components, (4) presentations reflecting the discussions, (5) questions to and answers from FDA, and (6) concluding remarks. The meeting provided useful information to the diabetes technology community and thoughtful feedback to FDA.

Investigational Drug Information

1974 ◽  
Vol 8 (1) ◽  
pp. 25-26
Author(s):  
Larry M. Kleinman ◽  
Joseph A Tangrea ◽  
Joseph F. Gallelli
Keyword(s):  
Clinical Research ◽  
Drug Administration ◽  
Drug Information ◽  
Food And Drug Administration ◽  
National Institutes Of Health ◽  
Investigational Drug ◽  
New Drug ◽  
Research Protocols ◽  
Clinical Center ◽  
Investigational Drugs

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.).

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