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July 24, 2020

Non-clinical Immunogenicity Assessment of Generic Peptide Products: Development, Validation, and Sampling – 01/26/2021 – 01/26/2021

On This Page Date: January 26, 2021 Time: 9:00 AM – 4:30 PM ET FDA is hosting a workshop to communicate current regulatory thinking and considerations […]
July 24, 2020

Drug Trials Snapshots: INQOVI

What are the possible side effects (results of trials used to assess safety)? The table below summarizes adverse reactions in the clinical trial. Table 5. Adverse […]
July 23, 2020

Coronavirus (COVID-19) Update: Daily Roundup July 23, 2020

For Immediate Release: July 23, 2020 The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 […]
July 23, 2020

FDA Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone

For Immediate Release: July 23, 2020 The U.S. Food and Drug Administration today announced it is requiring that labeling for opioid pain medicine and medicine to […]
July 23, 2020

Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert – FDA Recommends Health Care Professionals Discuss Naloxone with All Patients when Prescribing

[Posted 07/23/2020] TOPIC: Opioid Pain Relievers or Medicines to Treat Opioid Use Disorder: MedWatch Safety Alert  – FDA Recommends Health Care Professionals Discuss Naloxone with All […]
July 23, 2020

FDA-ASCO PUBLIC WORKSHOP: 2020 Clinical Outcome Assessments in Cancer Clinical Trials Fifth Annual Workshop – 07/22/2020 – 07/17/2020

On This Page Date: July 22 – 17, 2020 Time: 9:00 AM – 4:00 PM ET Twitter: #OCEOutcomes20  Co-Sponsor: American Society of Clinical Oncology (ASCO) Co-Chairs: […]
July 23, 2020

Information about Naloxone

Naloxone is a medication that rapidly reverses the effects of opioid overdose and is the standard treatment for overdose. In the wake of the opioid epidemic, […]
July 23, 2020

FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder

To reduce the risk of death from opioid overdose, the U.S. Food and Drug Administration (FDA) is making the following recommendations about the opioid reversal medicine, […]
July 23, 2020

Bone, Reproductive and Urologic Drugs Advisory Committee (BRUDAC) Roster

Applying for Membership on FDA Advisory Committees As part of the Food and Drug Administration’s (FDA’s) ongoing efforts to recruit qualified experts with minimal conflicts of […]
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