- Bureau of Biologics (FDA)
- compassionate use (Emergency Use IND)
- Investigational New Drug (IND)
- parallel track policy
Found 21 search result(s) for FDA.
Bureau of Biologics (FDA)
(HIV/AIDS Research: Its History & Future Meeting)
... Bureau of Biologics was established as a part of the FDA in 1972, after responsibility for monitoring the safety of vaccines, sera, and blood products was transferred ...
Mar 07, 2021
... Bureau of Biologics was established as a part of the FDA in 1972, after responsibility for monitoring the safety of vaccines, sera, and blood products was transferred ...
Mar 07, 2021
clinical trials (phases of clinical research)
(HIV/AIDS Research: Its History & Future Meeting)
... optimal use. "Postmarketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use ...
Jan 06, 2021
... optimal use. "Postmarketing studies, which are conducted after a treatment is approved for use by the FDA, provide additional information including the treatment or drug’s risks, benefits, and best use ...
Jan 06, 2021
EFV (efavirenz)
(HIV/AIDS Research: Its History & Future Meeting)
... EFV (efavirenz, Sustiva) is an NNRTI, and was approved by the FDA for use in 1998. It is sold as a triple combination with FTC (emtricitabine) and tenofovir as Atripla and Viraday ...
Jan 11, 2021
... EFV (efavirenz, Sustiva) is an NNRTI, and was approved by the FDA for use in 1998. It is sold as a triple combination with FTC (emtricitabine) and tenofovir as Atripla and Viraday ...
Jan 11, 2021
elvitegravir (EVG)
(HIV/AIDS Research: Its History & Future Meeting)
... Elvitegravir (EVG) is an integrase inhibitor developed by Gilead, and approved by the FDA in 2012. It is most commonly administered in combination with cobicistat, FTC (emtricitabine), and tenofovir, a combination ...
Jan 18, 2021
... Elvitegravir (EVG) is an integrase inhibitor developed by Gilead, and approved by the FDA in 2012. It is most commonly administered in combination with cobicistat, FTC (emtricitabine), and tenofovir, a combination ...
Jan 18, 2021
idoxuridine (5-iododeoxyuridine)
(HIV/AIDS Research: Its History & Future Meeting)
... antiherpes antiviral drug. It was developed by William H. Prusoff in the 1950s, and became the first FDA approved antiviral drug. Before the success of idoxuridine it was widely assumed that a chemical antiviral ...
Jan 11, 2021
... antiherpes antiviral drug. It was developed by William H. Prusoff in the 1950s, and became the first FDA approved antiviral drug. Before the success of idoxuridine it was widely assumed that a chemical antiviral ...
Jan 11, 2021
3.1 Marty St. Clair: Discovery of AZT as the First Anti-HIV Drug
(HIV/AIDS Research: Its History & Future Meeting)
... relative term, isn't it? We submitted the IND (Investigational New Drug application) to the FDA. Then we announced our discovery at ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy ...
Apr 27, 2021
... relative term, isn't it? We submitted the IND (Investigational New Drug application) to the FDA. Then we announced our discovery at ICAAC (Interscience Conference on Antimicrobial Agents and Chemotherapy ...
Apr 27, 2021
2.3 Mark Harrington — The Importance of Activism to the US Response
(HIV/AIDS Research: Its History & Future Meeting)
... we would get our way out of this epidemic. At the time, we believed that the FDA 00:04:30 was reviewing and approving drugs too slowly and not allowing them ...
Apr 27, 2021
... we would get our way out of this epidemic. At the time, we believed that the FDA 00:04:30 was reviewing and approving drugs too slowly and not allowing them ...
Apr 27, 2021
3.6 John C. Martin — Making it Simpler: A Single Pill to Treat HIV
(HIV/AIDS Research: Its History & Future Meeting)
... got approved for HIV because the dose needed for HIV was kidneytoxic. We had an FDA panel meeting in 1999, where the FDA asked for more clinical studies. However, we already had phase II ...
Apr 27, 2021
... got approved for HIV because the dose needed for HIV was kidneytoxic. We had an FDA panel meeting in 1999, where the FDA asked for more clinical studies. However, we already had phase II ...
Apr 27, 2021
6.1 Sharon Hillier — Development and Application of Pre-exposure Prophylaxis (PrEP)
(HIV/AIDS Research: Its History & Future Meeting)
... studies. We're guessing FDA, the dossier is going to be submitted in April next year. FDA approval or EMA could happen sometime in 2018. I think what we ... effective. It's a really 00:10:00 great strategy. Based on the strength of the ...
Apr 27, 2021
... studies. We're guessing FDA, the dossier is going to be submitted in April next year. FDA approval or EMA could happen sometime in 2018. I think what we ... effective. It's a really 00:10:00 great strategy. Based on the strength of the ...
Apr 27, 2021
3.2 Samuel Broder: The First Clinical Trials of Antiretroviral Drugs
(HIV/AIDS Research: Its History & Future Meeting)
... 3TC (lamivudine) was approved eight years later on November 17th, 1995. These are from the FDA website. #counterfactual history In other words, it took a long time to come up ...
Apr 27, 2021
... 3TC (lamivudine) was approved eight years later on November 17th, 1995. These are from the FDA website. #counterfactual history In other words, it took a long time to come up ...
Apr 27, 2021
4.1 Ronald Desrosiers — The Origin of SIVmac: Non-human Primate Models for HIV
(HIV/AIDS Research: Its History & Future Meeting)
... 31:30 the mechanism? Ronald: I would say now it's not, whether the FDA would feel that way, then crosstalk the FDA say you're going to deliver for 10 years, you're going to need a safety ...
Apr 27, 2021
... 31:30 the mechanism? Ronald: I would say now it's not, whether the FDA would feel that way, then crosstalk the FDA say you're going to deliver for 10 years, you're going to need a safety ...
Apr 27, 2021
Session 10: What Have We Learned?
(HIV/AIDS Research: Its History & Future Meeting)
... great skepticism. But now the communities are really embracing it and it’s really rolling out—FDA approval, CDC guidelines, reimbursement for PrEP. It’s really moving and it is highly 00 ...
Apr 27, 2021
... great skepticism. But now the communities are really embracing it and it’s really rolling out—FDA approval, CDC guidelines, reimbursement for PrEP. It’s really moving and it is highly 00 ...
Apr 27, 2021
8.6 David Baltimore — Bringing it to an End (And Where Are We Going?)
(HIV/AIDS Research: Its History & Future Meeting)
... We've teamed up with the Vaccine Research Center at NIH to do that clinical evaluation. The FDA did approve a general trial design, but now has some issues. We ...
Apr 27, 2021
... We've teamed up with the Vaccine Research Center at NIH to do that clinical evaluation. The FDA did approve a general trial design, but now has some issues. We ...
Apr 27, 2021
3.3 Douglas Richman: Antiviral Drug Resistance and Combination ART
(HIV/AIDS Research: Its History & Future Meeting)
... were myself and Bob Chanock’s lab and Dave Barry (1944–2002), who was at the FDA Bureau of Biologics where we became friends. That's sort of how I ...
Apr 27, 2021
... were myself and Bob Chanock’s lab and Dave Barry (1944–2002), who was at the FDA Bureau of Biologics where we became friends. That's sort of how I ...
Apr 27, 2021
9.2 Staffan Hildebrand — Face of AIDS Project
(HIV/AIDS Research: Its History & Future Meeting)
... Harbor Laboratory (CSHL) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12943828 Dwyer, John M. (b. 1939) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15535160 FDA (US Food and Drug Administration) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532107 fear https://libwiki.cshl.edu/confluence/display/AT/fear funding and grants https://libwiki.cshl.edu/confluence/display/AT/fundingandgrants ...
Apr 27, 2021
... Harbor Laboratory (CSHL) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=12943828 Dwyer, John M. (b. 1939) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15535160 FDA (US Food and Drug Administration) https://libwiki.cshl.edu/confluence/pages/viewpage.action?pageId=15532107 fear https://libwiki.cshl.edu/confluence/display/AT/fear funding and grants https://libwiki.cshl.edu/confluence/display/AT/fundingandgrants ...
Apr 27, 2021
8.5 Sharon Lewin — Research to a Cure: A Possible Goal?
(HIV/AIDS Research: Its History & Future Meeting)
... dose of vorinostat. We were able to use 14 days of vorinostat, something that the FDA was uncomfortable in approving here, but we have a different regulatory process in Australia. We ...
Apr 27, 2021
... dose of vorinostat. We were able to use 14 days of vorinostat, something that the FDA was uncomfortable in approving here, but we have a different regulatory process in Australia. We ...
Apr 27, 2021
2.6 Tony Fauci — 35 Years of HIV/AIDS: Science and Policy
(HIV/AIDS Research: Its History & Future Meeting)
... cofounder of TAG) and others. Here's another thing that's a wakeup call. Coming to the FDA, I think early on, they were 00:17:30 not so sophisticated, they thought ...
May 25, 2021
... cofounder of TAG) and others. Here's another thing that's a wakeup call. Coming to the FDA, I think early on, they were 00:17:30 not so sophisticated, they thought ...
May 25, 2021
2.4 Robert Gallo — Discoveries of Human Retrovirus, Their Linkage to Disease as Causative Agents & Preparation for the Future
(HIV/AIDS Research: Its History & Future Meeting)
... some of that yesterday, "poppers," amyl nitrate, particularly 00:15:30 from FDA by that time. But I noted from Jim Curran's slide, that he used to be at CDC ...
Apr 27, 2021
... some of that yesterday, "poppers," amyl nitrate, particularly 00:15:30 from FDA by that time. But I noted from Jim Curran's slide, that he used to be at CDC ...
Apr 27, 2021
2.2 James Curran — Deciphering the Epidemiology of AIDS
(HIV/AIDS Research: Its History & Future Meeting)
... already been about an 80% decline in transmissions through the blood supply because the FDA implementation of these recommendations. Then we should look at some temporary laboratory tests. People ...
Apr 27, 2021
... already been about an 80% decline in transmissions through the blood supply because the FDA implementation of these recommendations. Then we should look at some temporary laboratory tests. People ...
Apr 27, 2021
3.4 Raymond Schinazi — Discovery and Development of Novel NRTIs
(HIV/AIDS Research: Its History & Future Meeting)
Ray Schinazi: Thank you Bob Gallo. Thank you for inviting me and the rest of the gang. It's a pleasure to be here. I think that last time I was at Cold Spring Harbor, I was about 32 years old at a herpes meeting ...
Apr 27, 2021
Ray Schinazi: Thank you Bob Gallo. Thank you for inviting me and the rest of the gang. It's a pleasure to be here. I think that last time I was at Cold Spring Harbor, I was about 32 years old at a herpes meeting ...
Apr 27, 2021
9.1 Jon Cohen — Responding to AIDS: A Journalist's View
(HIV/AIDS Research: Its History & Future Meeting)
... had become a very large and powerful movement. They had already shut down the FDA. They had shut down Wall Street, and on May 21st, 1990, they shut down ...
Apr 27, 2021
... had become a very large and powerful movement. They had already shut down the FDA. They had shut down Wall Street, and on May 21st, 1990, they shut down ...
Apr 27, 2021