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Clinical Research Solutions
On August 28, 2015, FDA announced the availability of a draft guidance, entitled “Nonproprietary Naming of Biological Products,” which established a naming convention for biological products. The...
Clinical Research Solutions
On Wednesday, June 1st the FDA issued a draft guidance that provides various recommendations concerning studies to evaluate the adhesion performance of a Transdermal Delivery System (TDS) or a...
Clinical Research Solutions
On May 10th the Food and Drug Administration (FDA) published a final rule expanding regulation to a range of products that meet the statutory definition of a “tobacco product,” including...
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
Additional information on FDA’s final guidance is available in our preceding FDA News article, entitled “FDA Finalizes Guidance Containing Postmarket Surveillance Recommendations, Part One:...
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
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...
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
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...
Medical Information
Patient Support Programs (PSPs) in the pharmaceutical sector represent an array of aimed at supporting patients in initiating therapy and maintaining adherence. PSPs, also known as Patient Assistance...
Clinical Research Solutions
The link between statistical methods and healthcare is not a new one, but the volume of available data to inform healthcare decisions and the use of data science in the medical industry has exploded...
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...