Safe Ingredient Can Still Create a Compliance Failure
TGA says 23 batches of Nutra-Life and Musashi listed medicines used sucralose instead of thaumatin, creating inaccurate labels even though the products remain safe.
Category: FDA Compliance
FDA Guidance 2026: New August Updates Could Change How Sponsors Plan Generics, Biosimilars and CMC Programs
FDA’s August 2026 guidances update therapeutic equivalence, ANDA vs 505(b)(2), container closure systems and drug-development expectations.
The Label Said “Dietary Supplement.” FDA Found a Prescription Drug and a Toxic Industrial Chemical Inside.
FDA testing finds undeclared fluoxetine and toxic DNP in Lipofit Extreme Fat Burner 2.0, triggering a nationwide consumer recall.
A Clear IV Solution Can Still Carry a Serious Quality Risk
Baxter recalls two saline lots for potential fiberglass particulate contamination, raising injectable particulate-control questions
An FDA Approval Does Not Automatically Mean Two Drug Products Are Interchangeable
FDA finalizes guidance explaining therapeutic-equivalence evaluations and Orange Book TE codes for multisource prescription drugs.
Your Test Report Is Current. Is the Standard Behind It Still Current?
FDA Recognition List 066 changes recognized medical-device standards. Manufacturers should check active protocols and submissions.
FDA Just Finalized How Sponsors Should Prepare for Formal Meetings
FDA published final guidance on August 13, 2026 covering formal meetings between FDA and sponsors or applicants of products subject to the Prescription Drug User Fee Act. It applies to drug and biological products regulated by CDER and CBER and finalizes the draft issued in September 2023. This is guidance,…
FDA May Move Digital Breast Tomosynthesis From PMA to 510(k)
FDA has proposed reclassifying digital breast tomosynthesis (DBT) systems from Class III to Class II. If finalized, the change would replace the current PMA framework for these systems with Class II special controls plus 510(k) premarket notification requirements. For manufacturers, this could materially change both new-product submissions and lifecycle-management strategy.…
EMA’s Latest IDMP/PMS Update Is Really a Data-Governance Issue
EMA updated several Product Management Service/ISO IDMP implementation documents on August 12, including Chapter 3 covering the electronic submission and maintenance of medicinal-product information. For marketing authorization holders, this is less a “new regulation” story than a regulatory-data-governance story. The updated Chapter 3 is Version 3.7. EMA says this version…
FDA Eases Biosimilar Rules, Saves $20M in Costs
FDA’s 4th draft guidance revision streamlines biosimilar PK testing, allowing non-U.S. comparators with analytical justification to cut $20M costs and speed approvals.