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FDA approves drug to treat sickle cell disease in patients aged 4 up to 11 years
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315
FDA
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Risk Evaluation and Mitigation Strategy (REMS) Public Dashboard
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345
FDA
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Risk Evaluation and Mitigation Strategies | REMS
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373
FDA
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FDA Drug Competition Action Plan
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321
FDA
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Coronavirus (COVID-19) Update: December 17, 2021
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283
FDA
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FDA Approves New Treatment for Myasthenia Gravis
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312
FDA
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Search List of Extended Use Dates to Assist with Drug Shortages
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244
FDA
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Curriculum Materials for Health Care Degree Programs | Biosimilars
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278
FDA
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International regulators’ reflections on remote approaches to GCP and GMP regulatory oversight during COVID-19 pandemic, , 13/12/2021
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462
EMA
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New treatment for sickle cell disease, CHMP, 17/12/2021
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305
EMA
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EMA recommends approval for use of Kineret in adults with COVID-19, CHMP, 16/12/2021
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288
EMA
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COVID-19: EMA recommends authorisation of antibody medicine Xevudy, CHMP, 16/12/2021
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274
EMA
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Increase in manufacturing capacity for COVID-19 vaccines from Janssen, Moderna and BioNTech/Pfizer, CHMP, 16/12/2021
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311
EMA
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EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19, CHMP, 16/12/2021
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347
EMA
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Pediatric Review Committee (PeRC)
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407
FDA
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MedWatch: The FDA Safety Information and Adverse Event Reporting Program
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291
FDA
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DDT COA #000006: Asthma Daily Symptom Diary (ADSD)
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308
FDA
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DDT COA #000005: Diary for Irritable Bowel Syndrome Symptoms – Constipation (DIBSS-C)
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427
FDA
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Drug Compliance Programs
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305
FDA
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11th Annual Global Summit on Regulatory Science - 10/04/2021 - 10/06/2021
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258
FDA
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