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CBER’s agenda for 2018 states that it is considering the release of more than a dozen guidance documents, including new draft guidance on testing retroviral gene therapy products and on hemophilia gene therapy, along with revisions to its draft guidance on reducing the risk of Zika virus transmission. Read More
CDER published an agenda of 98 upcoming draft guidances for the 2018 calendar year — including new recommendations for developing treatments for Alzheimer’s and amyotrophic lateral sclerosis. Read More
The FDA is prioritizing the opioid crisis, innovation, and generic competition in the coming year, the agency said in its 2018 Strategic Policy Roadmap. Read More
The FDA issued a direct final rule removing the biennial inspection requirement for biologics production facilities and adopting a more flexible, risk-based approach to how often the agency will conduct inspections. Read More
CDER and CBER issued a joint data standards strategy detailing how the centers will develop and use data standards to review pre- and post-market safety and efficiency data through fiscal year 2022. Read More
Citing a public health emergency, a group of congressional Democrats called on HHS Secretary Alex Azar to use existing legislative authority to lower the price of hepatitis C virus treatments. Read More
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The draft guidance considers the appropriateness of pursuing an indication in a disease’s molecular subset depending on whether patients with the genetic alteration are more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