Clinical Research Solutions
FDA Draft Guidance on Tentatively Approved ANDA Submissions
FDA Draft Guidance on Tentatively Approved ANDA Submissions: On Wednesday, January 16th, the FDA published its first draft guidance since the partial government shutdown took effect on December 22,...
Clinical Research Solutions
Year in Review: Taking a Look at Pharma's Top News Stories & Events from 2018
From FDA's approval of the first cannabis-based product in the U.S., to the classification of two Apple Watch apps and changes in the Agency's submission requirements related to Sponsor meetings,...
Regulatory Sciences
FDA Advances its Biosimilar Policy Framework
On Tuesday, December 11th, FDA made large strides to advance its biosimilar policy framework, including the release of four guidance documents and a proposed rule. Through these guidance documents,...
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 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FDA Encourages Development of Novel Drugs for Rare Diseases with Draft Guidance Regarding the Role of Pre-IND Meetings
On Monday, October 12th, FDA issued a draft guidance regarding the role of Pre-IND Meetings in the development of drugs to treat rare diseases. The document, entitled "Rare Diseases: Early Drug...
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...
Regulatory Sciences
CBER Provides Sponsors with Policies & Procedures Regarding INTERACT Meetings
On Monday, October 1, FDA’s Center for Biologics Evaluation and Research (CBER) issued a document outlining the policies and procedures for scheduling and conducting INitial Targeted Engagement for...
Clinical Research Solutions
FDA Issues Final Guidance Regarding Content & Format Requirements for ANDA Submissions
On Tuesday, September 25th, the FDA issued a guidance document entitled “ANDA Submissions – Content and Format.” The document, initially issued as a draft guidance in June 2014, provides sponsors...