A blocked manometer port on the Ambu SPUR II resuscitator may delay ventilation or cause barotrauma
Similar Posts
FDA approves new treatment for acromegaly, a rare endocrine disorder
The U.S. Food and Drug Administration (FDA) approved Palsonify (paltusotine) tablets to treat adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option.FDA use of Real-World Evidence in Regulatory Decision Making
The studies presented in the accompanying tables exemplify instances in which the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) applied RWE in regulatory decision-making processes since 2011.Oncology (Cancer)/Hematologic Malignancies Approval Notifications
FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products.Prescription Drug User Fee Amendments
The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.FDA Drug Competition Action Plan
FDA’s Drug Competition Action Plan (DCAP) encourages robust and timely market competition for generic drugs and helps bring greater efficiency and transparency to the generic drug review process, without sacrificing the scientific rigor underlying our generic drug program.HealBerry – 09/09/2025
Unlawful Sale of Unapproved and Misbranded Drugs to United States Consumers Over the Internet