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Clinical Research Solutions
In September 2007, the Prescription Drug User Fee Act (PDUFA IV) was reauthorized and expanded, broadening and strengthening FDA’s drug safety program. As part of PDUFA’s reauthorization, the Agency...
Clinical Research Solutions
According to an infographic report from the California Life Sciences Association (CLSA), FDA approval times have decreased by nearly 50% since 2009. The infographic, entitled “Tracking FDA Drug...
Clinical Research Solutions
More on FDA’s draft guidance in our preceding FDA News article, entitled “FDA Releases Anxiously Awaited Biosimilar Labeling Guidance, Part 1: An Overview of FDA’s Recommendations.” Late last month...
Clinical Research Solutions
On Thursday, March 31st, FDA released a highly anticipated draft guidance addressing the requirements for biosimilar labels. The draft guidance, entitled “Labeling for Biosimilar Products,” is...
Clinical Research Solutions
At the time of this writing, there were 59 registered 503b outsourcing facilities posted on the FDA’s website. All firms that had been inspected were issued FDA inspectional observations in the form...
Clinical Research Solutions
On Monday, April 4th, FDA announced a publication entitled “Modifications to the List of Recognized Standards, Recognition List Number: 041,” which contains modifications to the list of standards FDA...
Clinical Research Solutions
FDA Touches on Routes of Abuse, Comparative In Vitro Studies, and Various Other Factors to Consider Regarding Abuse-Deterrent Generic Opioids Due to recent increases in the prevalence of opioid abuse...
Clinical Research Solutions
On Wednesday, March 30th, FDA approved a new label for Mifeprex® (mifepristone), the medical abortion pill. The FDA stated that the drug is both safe and effective when taken in lower doses and up to...
Clinical Research Solutions
On Monday, March 28th the FDA announced that it is amending its current IND and bioequivalence regulations. Specifically, FDA stated that it is changing “its regulations to update the address for...
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...