Latest FDA Stories
The San Diego injury law firm discusses birth defect allegations associated with Zofran use, as two recently filed lawsuits allege that Zofran manufacturer GlaxoSmithKline failed to inform doctors
- First atypical antipsychotic to be approved for pediatric patients with bipolar I disorder in the last five years - DUBLIN, March 13, 2015 /PRNewswire/ -- Actavis plc (NYSE: ACT) today announced
The FDA requires drug and device makers to conduct regular effectiveness checks on their recall processes.
Devicemakers must take steps now to secure a production account for submitting electronic Medical Device Reports (eMDRs), ahead of an Aug. 14, 2015 deadline for compliance.
NIMS enables faster, deeper and more insightful regulatory review of nonclinical study data for safety signal detection and analysis SILVER SPRING, Md., March 12, 2015 /PRNewswire/
ATLANTA, March 12, 2015 /PRNewswire/ -- CryoLife, Inc.
It’s estimated that 75% of device manufacturers conduct internal audits solely “because we have to – because the FDA and ISO regs say so.” In just 90 minutes, attendees will be shown why
The announcement that a new drug has been granted “orphan” status by the FDA could pave the way for an alternative mesothelioma therapy. Raleigh, NC (PRWEB)
- PharmaEssentia and AOP Orphan announce completion of recruitment of the pivotal European Phase III trial PROUD-PV (www.proud-pv.com) to support global marketing of P1101 (Ropeginterferon alfa-2b).
Patients who suffer from symptoms of laryngopharyngeal reflux (LPR) may now find relief with this novel new medical device GERMANTOWN, Wis., March 10, 2015 /PRNewswire/ -- Somna Therapeutics
- A serpent whose bite was fabled to produce intense thirst.