Clinical Research Solutions
FDA Proposes Changes to the De Novo Pathway
On Tuesday, December 4th, FDA published the De Novo Classification Proposed Rule. If finalized, the rule would establish procedures for the De Novo classification process by facilitating appropriate...
Clinical Research Solutions
Outsourcing Functions Doesn't Mean You've Outsourced Compliance Obligations
Over the past 20 years, the traditional approach to drug development has expanded to include the outsourcing of a range of testing and manufacturing functions. As a part of their long-term strategic...
Clinical Research Solutions
FDA Takes Steps to Promote Digital Tools for Prescription Drugs
On Tuesday, November 20th, FDA announced the establishment of a public docket to solicit comments and feedback on a proposed framework regarding the regulation of prescription drug-use-related...
Clinical Research Solutions
FDA to Modify Informed Consent Rules, Seeks Feedback
On Tuesday, November 13th, FDA proposed to add an exception to its informed consent requirements for minimal risk FDA-regulated clinical investigations. Under the Agency’s current regulations,...
Clinical Research Solutions
FDA Approves New Opioid Despite Controversy
On Friday, November 2nd, FDA announced its approval of Dsuvia™, a highly potent synthetic opioid manufactured by AcelRx Pharmaceuticals, Inc. The drug is a sublingual (under the tongue) formulation...
Clinical Research Solutions
FDA Seeks Feedback on Surrogate Endpoint Table
On December 13, 2016, the 21st Century Cures Act was signed into law with the intention of speeding FDA’s approval time for drugs and medical devices. When signed, the Cures Act increased FDA’s...
Clinical Research Solutions
FDA Tackles Opioid Epidemic with SUPPORT Act & Global Operation Targeting Websites Selling Illegal Drugs
Last week, the FDA published two statements regarding its involvement in efforts to combat the opioid epidemic afflicting the U.S. FDA Cracks Down on Websites Selling Illegal Opioids On Tuesday,...
Clinical Research Solutions
FDA Approves Single-Dose Flu Drug Just in Time for Flu Season
On Wednesday, October 24th, FDA approved Xofluza (baloxavir marboxil), a single-dose oral flu medication. The product is indicated for the treatment of acute uncomplicated influenza (flu) in patients...
Clinical Research Solutions
Human Subject Protection Regulations: Differences Between HHS’ & FDA’s Clinical Trial Rules
On Friday, October 12th, FDA issued a guidance document entitled “Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations.” The document aims to help...
Clinical Research Solutions
Pros and Cons of Working with a CRO
Sponsors may transfer any or all of their many tasks and obligations relating to clinical trials to Contract Research Organizations (CROs). This ability to delegate through a Transfer of Regulatory...