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UPDATED TIME INFORMATION: November 4, 2021: Meeting of the Psychopharmacologic Drugs Advisory Committee (PDAC) Meeting Announcement - 11/04/2021
Source: What's New: Drugs Published on 2022-01-20
Alma LeVant Hayden's Contributions to Regulatory Science
Source: What's New: Drugs Published on 2022-01-20
Blood Grouping and Phenotyping Reagents
Source: What's New: Vaccines and Biologics Published on 2022-01-20
Safety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate
Source: What's New: Drugs Published on 2022-01-20
Safety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)
Source: What's New: Drugs Published on 2022-01-20
Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
Source: What's New: Drugs Published on 2022-01-20
FDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
Source: What's New: Drugs Published on 2022-01-20
FDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
Source: What's New: Drugs Published on 2022-01-19
FDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
Source: What's New: Drugs Published on 2022-01-19
Orange Book Preface
Source: What's New: Drugs Published on 2022-01-19
FDA Drug Safety Podcast: FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
Source: What's New: Drugs Published on 2022-01-19
FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease
Source: What's New: Drugs Published on 2022-01-19
FDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer
Source: What's New: Drugs Published on 2022-01-19
FDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
Source: What's New: Drugs Published on 2022-01-19
Patient Engagement & Regenerative Medicine: An FDA CBER Workshop for Patient Advocates - 05/06/2021
Source: What's New: Vaccines and Biologics Published on 2022-01-19

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Quality Smart Solutions is a global consulting firm, engaged in providing strategic support for products including NHPs, pharmaceuticals, and medical devices, in areas such as Regulatory Support, Site Licensing, Clinical Development and more.

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