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NEW MEDICINES AND DRUG DISCOVERY · FDA: DRUGS · 29 October 2026

Newly Added Guidance Documents

Synopsis

Newly Added Guidance Documents Topic Guidance Status Date Combination Products Essential Drug Delivery Performance Characteristics for Devices Intended to Deliver Drugs and Biological Products Draft 10/29/2026 Technical Specifications Submitting Clinical Trial Data to Evaluate the Ability to Operate a Motor Vehicle Final 10/20/2026 Labeling Regulatory Considerations for Prescription Drug Use-Related Software Final 10/20/2026 Biosimilars Postapproval Manufacturing Changes to B

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