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Although 2017 saw significantly fewer new FDA regulations, other regulatory and enforcement activities at the agency built on existing long-term trends, according to a new report from PriceWaterhouseCoopers (PwC). Read More
Biocom recommended the guidance “provide greater clarity on the level of evidence required for RMAT designation” compared to breakthrough and fast-track designations. Read More
The draft guidance considers the appropriateness of pursuing an indication in a disease’s molecular subset depending on whether patients with the genetic alteration are more likely to respond to the targeted therapy. Read More
The FDA’s Office of Prescription Drug Promotion sent an untitled letter to Collegium Pharmaceutical of Canton, Massachusetts for downplaying the risks of its extended release opioid drug Xtampza ER in an exhibit booth at an American Society of Health-System Pharmacists meeting last summer. Read More
A federal judge ruled in favor of the FDA’s decision to deny Amgen market exclusivity for the pediatric dialysis drug Sensipar (cinacalcet), saying the company failed to prove the FDA applied different standards in its review. Read More
Sponsors submitting NDA and BLA content for bioresearch monitoring inspections should list all relevant clinical sites and entities responsible for clinical study-related activities, according to new draft guidance from the FDA on standardized formatting for BIMO inspection submissions. Read More
FDA guidance that proposes to close what the agency sees as a “loophole” allowing drug developers to bypass pediatric study requirements would negatively impact child drug development if it becomes final, according to some drug developers and patient advocacy groups. Read More
PhRMA, Merck and Illumina offered feedback on the FDA’s draft guidance on the development of treatments that target diseases caused by molecular alterations, requesting the agency provide more details. Read More
The FDA revised its Manual of Policies and Procedures document pertaining to issuing complete and partial clinical holds, including a reorganized background section that consolidates descriptions of IND clinical hold procedures, CFR citations and timelines for agency responses to sponsors. The new version also narrows its focus by omitting references to general IND review procedures included in the previous version that took effect in May 1998. Read More