Clinical Research Solutions
On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab)....
Clinical Research Solutions
On Thursday, April 20th, the FDA formally ordered both Texas and Arizona to refuse and either destroy or export all execution drugs within 90 days. Background Texas was the first state to begin...
Clinical Research Solutions
On Thursday, April 20th, the FDA issued a statement announcing a number of changes that are being made to the labeling requirements for two opioids – codeine and tramadol. The Agency’s statement...
Clinical Research Solutions
On Friday, March 31st, the FDA informed consumers of “Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products.” These...
Clinical Research Solutions
On Tuesday, March 28th, the FDA announced the approval of Dupixent (dupilumab), an injection for the treatment of adults with moderate-to-severe atopic dermatitis. What is Atopic Dermatitis? Atopic...
Clinical Research Solutions
Sponsors no longer have to rely on checking lists of 510(k) devices when looking to make a substantial equivalence claim. While the FDA does release an updated list each month, Sponsors can save time...
Clinical Research Solutions
On Monday, March 6th, the FDA announced plans to hold a public meeting regarding the development of patient-focused drugs for autism. In the notice published in the Federal Register, the FDA notes...
Clinical Research Solutions
In a recent post on the FDA Voice blog, the Agency reported that its generic drug program hit record highs in 2016. In the blog post, Kathleen “Cook” Uhl, M.D., Director of FDA’s Office of Generic...
Clinical Research Solutions
On Friday, February 24th, FDA issued a press release stating that Endo Pharmaceuticals Inc. is recalling one lot of Edex® (alprostadil for injection) 10 mcg. What is Edex? Edex is a prescription only...
Clinical Research Solutions
On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process. If passed, the bill would amend the...