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Clinical Research Solutions
On Thursday, May 26th, FDA announced the approval of Probuphine® , a buprenorphine implant for the treatment of opioid dependence. The implant is the first device of its kind, and “is designed to...
Clinical Research Solutions
Earlier this week Samsung Bioepis announced that FDA has accepted for review its BLA for SB2, a biosimilar version of Remicade (infliximab). SB2 is indicated for the treatment of rheumatoid...
Clinical Research Solutions
On Wednesday, May 18th, FDA issued a Drug Safety Communication alerting the public of potential risks associated with canagliflozin (Invokana, Invokamet), which is used for the treatment of type 2...
Clinical Research Solutions
On Monday, May 16th, the FDA issued a final guidance, entitled “Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act.” A draft of the guidance was published on August...
Clinical Research Solutions
Every year on or near May 20th, Clinical Trials Day is celebrated. The internationally observed celebration recognizes the first randomized clinical trial, conducted in 1747 by James Link. In a...
Clinical Research Solutions
The Reagan-Udall Foundation for the FDA (RUF), a non-profit organization created to help the FDA accomplish its mission, is in the process of developing an online Navigator to help patients and...
Clinical Research Solutions
Additional information on FDA's draft guidance is available in our preceding FDA News article, entitled "FDA Expands on Recommendations Regarding Use of EHR Data in Clinical Trials, Part One:...
Clinical Research Solutions
On Tuesday, May 17, FDA announced the availability of a new draft guidance, entitled “Use of Electronic Health Record Data in Clinical Investigations.” The document, which expands on the...
Clinical Research Solutions
On Thursday, May 12th, the FDA issued a warning regarding fluoroquinolone antibacterial drugs, stating that the associated side effects “generally outweigh the benefits for patients with sinusitis,...
Clinical Research Solutions
In order to incentivize the development of therapies (drugs biologics) to fill unmet medical needs for treatment of serious conditions, the FDA has developed various programs to expedite drug...
Clinical Research Solutions
Part 1 of this series discussed confidence intervals. Confidence intervals are the best known of the statistical intervals but they only bound regions associated with population parameters; i.e., the...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector offer a range of services to help patients start and adhere to their therapies, including Patient Assistance Programs (PAPs), patient...
Clinical Research Solutions
What is a Clinical Study Report? A Clinical Study Report (CSR) is a document that describes the methods and results of a clinical study or trial, along with a short discussion of key findings related...
Regulatory Sciences
Compiling and submitting a New Drug Application (NDA) submission is a complicated and intensive activity. Once you have submitted your application to FDA, you may be curious about what can you expect...
Regulatory Sciences
This article has been updated since its original February 28, 2017 publication. Since the introduction of the Prescription Drug User Fee Act (PDUFA) VII for fiscal years 2023 - 2027, the FDA...