FDA News


FDA Takes Big Steps to Advance 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, FDA intends to maintain efficient regulatory processes for innovative and generic drug products. The first draft and final guidance documents provide “greater clarity on scientific and […] READ MORE...


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 classification for new medical devices. The proposed rule provides structure, clarity, and transparency for the De Novo process.  It establishes rules for the submission and withdrawal of […] READ MORE...


FDA Announces Plans to Modernize its 510(k) Medical Device Approval Process

On Monday, November 26th, FDA announced changes to modernize the 510(k) clearance pathway, which is the most common medical device submission and allows for the allows for the “clearance of low- to moderate-risk devices that are substantially equivalent to a device already on the market – otherwise known as a predicate device.”  The changes will […] READ MORE...


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 software applications. In a recent Federal Register notice, the Agency defines prescription drug-use-related software as “software disseminated by or on behalf of a drug sponsor that accompanies one […] READ MORE...


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, informed consent must be provided by subjects before participating in a trial. The only exceptions under current FDA regulation is if the subject is in a life threatening situation […] READ MORE...


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...