FDA Drafts Guidance on Target Product Profiles and Issues 2007 Agenda
Regardless of the drug development strategy used, or whether an oral or long-acting injectable formulation is developed, the revised TPP provides guidance to the desired attributes of the next-generation chemoprevention drugs (Table 1). Table 1 Target product profile for malaria chemoprevention Full...
The FDA provides guidance on the type of evidence required to establish therapeutic effectiveness (FDA, 2019). Two adequate and well-controlled investigations or one adequate and well-controlled large multicenter trial that can provide substantial evidence of effectiveness are generally required to meet ...
For example, companies can use the examples listed in this guidance to determine how to handle an influencer or celebrity who is not affiliated with the product and isspreading misinformation in the media. In general, the guidance offers steps for companies to assist in addressing me...
New FDA guidance addresses how to incorporate assessment of patient-reported outcomes in cancer clinical trials of drugs and biological products.
TPPs are strategic tools used to provide guidance during drug discovery and development. While not mandatory, the US Food and Drug Administration (FDA) has published draft TPP guidelines [5], as these documents facilitate communication with regulators. As a minimum, TPPs provide platforms for a sh...
“Such a policy,” writes Reynolds regarding its desired enforcement scheme, “will close an existing loophole in FDA's current tobacco enforcement efforts, especially when it comes to youth.” The “loophole” Reynolds refers to is in the FDA’s February 2020 enforcement guidance, whichexemp...
In these systems, active guidance to a specified surgical target is designed for neurosurgical procedures (eg, ventriculostomy), not endoscopic sinus surgery (ESS). Scopis Building Blocks (Scopis, GmbH, Berlin, Germany) planning software allows the user to annotate a preoperative CT scan to high...
The FDA released guidance surrounding the use of digital health technologies and remote data collection during clinical investigations.
FDA issues draft guidance to enroll more participants from underrepresented racial and ethnic populations in the United States into trials, expanding overall clinical trial diversity.