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April 24, 2017
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...
April 18, 2017
On Friday, April 14th, a draft bill was released, aimed at reauthorizing the user fee programs for branded and generic drugs, medical devices, and biosimilar products. Committees from the House of...
April 7, 2017
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...
April 6, 2017
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...
March 24, 2017
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...
March 7, 2017
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...
March 6, 2017
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...
March 2, 2017
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...
February 27, 2017
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...