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The CDER Office of Pharmaceutical Quality (OPQ) Experiential Learning Site Visit Program (ELSVP) is inviting pharmaceutical companies interested in participating to submit a site visit proposal. Read More
CDER’s Office of Surveillance and Epidemiology (OSE) made significantly more use of AI and machine learning tools in 2023 to reduce the demands of manual reviews, according to OSE’s latest annual report. Read More
The FDA has announced the availability of the International Council of Harmonisation (ICH) final guidance and questions and answers on drug interaction studies and ICH has issued a final guideline on bioequivalence (BE) studies. Read More
Mirati Therapeutics has been issued an untitled letter by the FDA for making misleading online claims about the efficacy of its non-small cell lung cancer (NSCLC) drug Krazati (adagrasib), violations considered especially egregious by the agency due to the condition’s serious and devastating nature. Read More
The FDA has determined that the phase 3 SIERRA trial conducted by Actinium Pharmaceuticals is not adequate to support a BLA filing for Iomab-B to treat patients with active relapsed or refractory acute myeloid leukemia, the company recently announced. Read More
CDER’s Office of New Drugs (OND) touted accomplishments by the research program it launched in 2019 to address knowledge gaps identified during regulatory reviews. Read More
This edition of Quick Notes features an additional indication approval for Palforzia, phase 3 trial results for AstraZeneca’s Calquence, warning from FDA for compounded semaglutide and FDA approval of an alopecia treatment. Read More
The FDA has developed an AI tool to help its drug application reviewers and researchers identify changes to adverse event (AE) terms made when a drug’s labeling is updated. Read More
With the House and Senate now in recess until Sept. 9, the FDA is once again facing into a new fiscal year unsure of its funding from Congress. Read More
Despite a mostly lukewarm reception to phase 2/3 trial findings, the FDA’s Genetic Metabolic Diseases Advisory Committee voted 11-5 in support of approving Zevra Therapeutics’ arimoclomol for type C Niemann-Pick disease in patients age two years and up. Read More
In an effort to improve access to clinical research in the US and ease enrollment challenges, the Milken Institute has published a new report focusing on distance as a barrier to trial participation, digging deep into demographics and distribution of trials across US counties, as well as offering an interactive map tool filterable by therapeutic area. Read More
This edition of Quick Notes includes EU approval of Pfizer’s hemophilia B gene therapy Durveqtix, a positive EMA opinion on an expanded label for Wegovy, two new EMA draft guidelines on oligonucleotides and active substances, and an EMA paper on the data needed to show the equivalence of nasal products that contain the same active molecule. Read More