The Food and Drug Administration (FDA) has regulated most over-the-counter (OTC) drugs—that is, drugs available without a prescription—through the OTC monograph process. FDA has described an OTC monograph as a “rulebook” for marketing safe and effective OTC drugs, such as aspirin, cough and cold medicine, and hand sanitizer. OTC monographs …
Roche’s rheumatoid arthritis drug Actemra (tocilizumab) failed to provide benefit in a phase 3 trial evaluating it for treatment of hospitalized COVID-19 patients with severe pneumonia. Roche on Wednesday, announced that the phase III COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in …
The U.S. Food and Drug Administration (FDA) have published an update with the interim results from the Essure Postmarket Surveillance (“522”) Study. Although Essure is no longer being manufactured or distributed, the FDA had required the manufacturer undertake a post-market surveillance study. Early results show that Essure patients tend to …
The WHO Pharmaceuticals has released the Newsletter which provides you with the latest information on the safety of medicines and legal actions taken by regulatory authorities around the world. It also provides signals based on information derived from the WHO global database of individual case safety reports, VigiBase. Click below …
Cosmetics are defined by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. The products covered under this definition are skin moisturizers, perfumes, …
Labels for opioid pain medicines and opioid use disorder (OUD) treatments must now include a recommendation that naloxone availability be discussed as a routine part of prescribing these medicines, says the US Food and Drug Administration (FDA). “We are requiring the drug manufacturers for all opioid pain relievers and medicines to …
The US Food and Drug Administration (FDA) has approved an oral solution of calcium, magnesium, potassium, and sodium oxybates (Xywav, Jazz Pharmaceuticals) for treatment of cataplexy or excessive daytime sleepiness (EDS) in patients as young as age 7 years with narcolepsy. Xywav is a novel oxybate product with a unique …
The European Medicines Agency (EMA) has set up an infrastructure to support the monitoring of the efficacy and safety of COVID-19 treatments and vaccines used in day-to-day clinical practice. According to the EMA, this is underpinned by three contracts for observational research that the agency has signed with academic and private partners …
Cosmetovigilance is a new concept of safety monitoring of cosmetic products which refers to the post marketing surveillance of any health related undesirable effects possibly due to the use of cosmetic products. The purpose of Cosmetovigilance is to collect, analyze and assess the adverse reactions occurring in consumers to identify …
The combination of ticagrelor plus aspirin is superior to aspirin alone in reducing the risk for secondary stroke, transient ischemic attack (TIA), and death, new data show. However, severe bleeding was more common in the ticagrelor-aspirin group than in the aspirin-only group. “We found that ticagrelor plus aspirin reduced the risk of …
