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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
Section 505B(d)(1) requires FDA to send a PREA Non-Compliance letter to sponsors who have failed to submit their pediatric assessments required under PREA by the final due date, have failed to seek or
Read MoreAltis says its AI tool can cut risk in cancer trials
Biotech stories you need to read, brought to you by The Readout.
Read MoreVax Skeptic to Lead Autism Study; Liver Damage After RFK Jr. Recs; 'Chemtrail' Bans?
(MedPage Today) -- Note that some links may require registration or subscription. MedPage Today is collecting stories of HHS staffers across all agencies affected by Trump administration cuts.
Read MoreSTAT+: Pharmalittle: We’re reading about drug net prices inching up, uncertain pharma M&A, and more
Investment bankers say large pharma and biotech deals are stalling as executives grapple with mercurial White House economic policies
Read MoreSTAT+: Wave to submit Duchenne drug for approval after Phase 2 success
Wave Life Sciences’ experimental treatment for Duchenne muscular dystrophy hit the mark in a mid-stage study, setting the stage for a new therapeutic option for patients.
Read MoreAbbreviated New Drug Application (ANDA) Forms and Submission Requirements
The FDA aspires to assist applicants in developing abbreviated new drug applications (ANDAs).
Read MoreThe need-to-know on yesterday’s health leadership votes & noms
And more of the essential health news stories of the day.
Read MoreApprovals & Reports
FDA publishes a list of first-time approvals to manufacture generic drugs and a variety of reports on generic drug application reviews.
Read MoreSenate Confirms Trump's Nominees to Head NIH and FDA
(MedPage Today) -- The Senate on Tuesday evening confirmed Jay Bhattacharya, MD, as the next NIH director, and Marty Makary, MD, MPH, as the next FDA commissioner.
Read MoreGlobalData forecasts China neurosurgical robotics market to grow at 10% CAGR through 2036
China’s neurosurgical robotics market expansion driven by rising demand for precision surgery and strategic local partnerships
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