FDA News


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 of sufentanil that is injected with a disposable, pre-filled, single dose syringe.  “Dsuvia is indicated for the management of acute pain in adults that is severe […] READ MORE...


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 authority in a variety of areas.  It also created a number of new mandates that the Agency is required to comply with, […] READ MORE...


FDA Encourages Development of Novel Drugs for Rare Diseases with Draft Guidance Regarding the Role of Pre-IND Meetings

On Monday, October 12th, FDA issued a draft guidance regarding the role of Pre-IND Meetings in the development of drugs to treat rare diseases.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 Development and the Role of Pre-IND Meetings,” touches on four main issues to consider in the early phases of development and Pre-IND Meetings.  These […] READ MORE...


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, October 23rd, FDA issued a press release announcing its partnership with international regulatory and law enforcement agencies to target websites that are illegally selling unapproved […] READ MORE...


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 12 years of age and older who have had symptoms for no more than 48 hours. Xofluza’s safety and efficacy was demonstrated in two randomized controlled clinical […] READ MORE...


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 sponsors, investigators, and institutional review boards (IRBs) comply with the different human subject protection regulations of each agency, and focuses on informed consent, expedited review procedures, and […] READ MORE...


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 Regulatory Advice on CBER ProducTs (INTERACT) meetings.  The document, entitled “SOPP 8214: INTERACT Meetings with Sponsors for Drugs and Biological Products,” applies to all products regulated by […] READ MORE...


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 with information regarding the information that should be included in abbreviated new drug application (ANDA) submissions. Background Section 505(j) of the FD&C Act The Drug […] READ MORE...


Good Review Management Principles & Practices, Part Two: Operational Principles

Details on the fundamental values outlined on FDA’s GRMP draft guidance are available in our preceding article, entitled “Good Review Management Principles & Practices, Part One: Fundamental Values“ On September 25, 2018, the FDA issued a draft guidance entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications.”  The document […] READ MORE...


Good Review Management Principles & Practices, Part One: Fundamental Values

On Tuesday, September 25th, the FDA published a draft guidance containing recommendations on good review management principles and practices (GRMPs) for new drug applications (NDAs), Biologics license applications (BLAs), or efficacy supplements/supplements with clinical data.  The document, entitled “Good Review Management Principles and Practices for New Drug Applications and Biologics License Applications,” applies to human […] READ MORE...