Some articles on fda:
Chronic Fatigue Syndrome Treatment - Antiviral Treatments - Ampligen
... Food and Drug Administration (FDA) refused to approve a New Drug Application (NDA) to market and sell Ampligen for treatment of CFS ... The FDA concluded that the two RCTs submitted "did not provide credible evidence of efficacy." Hemispherx Biopharma performed additional analyses on their data and submitted a new NDA to the FDA in 2012 ... After reviewing the data, the FDA rejected the new application due to "insufficient safety and efficacy data" ...
... Food and Drug Administration (FDA) refused to approve a New Drug Application (NDA) to market and sell Ampligen for treatment of CFS ... The FDA concluded that the two RCTs submitted "did not provide credible evidence of efficacy." Hemispherx Biopharma performed additional analyses on their data and submitted a new NDA to the FDA in 2012 ... After reviewing the data, the FDA rejected the new application due to "insufficient safety and efficacy data" ...
Selmedica
... and an FDA registered drug and dietary supplement manufacturer The FDA Food and Drug Administration issued a Warning Letter to Selmedica in 2005 regarding its marketing practices ... who did not exist, fraudulently claimed FDA approval of his products, and engaged in other deceptive activities in promoting Selmedica products ...
... and an FDA registered drug and dietary supplement manufacturer The FDA Food and Drug Administration issued a Warning Letter to Selmedica in 2005 regarding its marketing practices ... who did not exist, fraudulently claimed FDA approval of his products, and engaged in other deceptive activities in promoting Selmedica products ...
Criticism Of The Food And Drug Administration
... Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most ... The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on ... found major deficiencies in the FDA system for ensuring the safety of drugs on the American market ...
... Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most ... The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on ... found major deficiencies in the FDA system for ensuring the safety of drugs on the American market ...
Lorcaserin - Time Schedule
... On 23 October 2010, the FDA decided not to approve the drug based on the available data ... and additional information submitted to the FDA, an advisory panel was convened on 10 May 2012 ... panel voted 19-4-1 to recommend lorcaserin to the FDA ...
... On 23 October 2010, the FDA decided not to approve the drug based on the available data ... and additional information submitted to the FDA, an advisory panel was convened on 10 May 2012 ... panel voted 19-4-1 to recommend lorcaserin to the FDA ...
Selectra - History
... Food and Drug Administration (FDA) in 1991 based on the recommendation of the Psychopharmacological Drugs Advisory Committee it had already become available in the United Kingdom the previous year ... The FDA committee achieved a consensus that sertraline was safe and effective for the treatment of major depression ... During the discussion, Paul Leber, Director of the FDA Division of Neuropharmacological Drug Products, noted that granting approval was a "tough decision", since the treatment effect on ...
... Food and Drug Administration (FDA) in 1991 based on the recommendation of the Psychopharmacological Drugs Advisory Committee it had already become available in the United Kingdom the previous year ... The FDA committee achieved a consensus that sertraline was safe and effective for the treatment of major depression ... During the discussion, Paul Leber, Director of the FDA Division of Neuropharmacological Drug Products, noted that granting approval was a "tough decision", since the treatment effect on ...