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August 22, 2019
On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications. In the report, GAO comments on the number of products approved on the first review...
July 22, 2019
On, Tuesday, June 11th, 2019, the FDA issued a final guidance document entitled “Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems.” The guidance was published less than...
July 11, 2019
In a new draft guidance released by the FDA on July 11th, the promise was made for access to quantitative data on maximum daily exposure levels (MDEs) of excipients by October 1, 2020. This will go a...
March 15, 2019
On Thursday, March 7th, FDA published a revised draft guidance, updating its nonproprietary naming convention for biological products licensed under section 351 of the Public Health Service Act (PHS...
March 11, 2019
Earlier this month, FDA announced the approval of Spravato (esketamine) nasal spray. The product is to be used in conjunction with an oral antidepressant and is indicated for the treatment of...
February 28, 2019
On Tuesday, February 19th, FDA published a draft guidance for medical device makers which identifies a process for companies to request nonbinding feedback on certain FDA Form 483 deficiencies noted...
February 22, 2019
On Wednesday, February 6th, FDA issued a letter to health care providers to increase the awareness of an association between all breast implants and Breast Implant Associated-Anaplastic Large Cell...
February 18, 2019
On Wednesday, February 6th, FDA approved the Cablivi®(caplacizumab-yhdp) injection, the first product approved in combination with plasma exchange and immunosuppression specifically for adults with...
February 12, 2019
On Tuesday, February 5th, FDA published a draft guidance explaining the principles for premarket review of combination products, including how to determine which type of premarket submission is...