Pharmaceutical industry news
Fresh coverage across pharma, biotech, medtech, research, approvals, and market-moving developments.
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Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Questionnaire and Data Collection Testing, Evaluation, and Research for the Health Resources and Services Administration, OMB No. 0915-0379-Revision
In compliance with the requirement for opportunity for public comment on proposed data collection pr...
Submission for Office of Management and Budget Review; Personal Responsibility Education Program (PREP) Performance Measures
The Office of Planning, Research, and Evaluation (OPRE) and the Family and Youth Services Bureau (FY...
Authorization of Emergency Use for Two Animal Drugs for the Prevention and Treatment of New World Screwworm; Availability
The Food and Drug Administration (FDA or the Agency) is announcing the issuance of two Emergency Use...
Agency Information Collection Activities; Proposed Collection; Comment Request; Extralabel Drug Use in Animals
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Current Good Manufacturing Practice Regulations for Type A Medicated Articles and Medicated Feeds
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has b...
SpecGx LLC; Withdrawal of Approval of Abbreviated New Drug Application for Methylphenidate Hydrochloride Extended-Release Tablets, 27 Milligrams, 36 Milligrams, and 54 Milligrams
The Food and Drug Administration (FDA or Agency) is withdrawing approval of abbreviated new drug app...
UPDATE: Hintermann Series H3 Total Ankle Replacement Has a Higher-Than-Expected Risk of Device Failure: FDA Safety Communication
Learn more about recommendations for patients who are considering a Hintermann Series H3 TAR system...
Medical Devices; Radiology Devices; Classification of the Radiological Machine Learning-Based Quantitative Imaging Software With Predetermined Change Control Plan
The Food and Drug Administration (FDA) is classifying the radiological machine learning-based quanti...
Medical Devices; Gastroenterology-Urology Devices; Classification of the Ingestible Gastrointestinal Blood Detection Capsule
The Food and Drug Administration (FDA) is classifying the ingestible gastrointestinal blood detectio...






