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.
Flash News
Health Canada Wants Faster Clinical Trial Registration and Results Disclosure. Is Your Process Ready?
Health Canada now expects covered clinical trials to be registered within 21 days of first participant enrollment and summary results to be disclosed within 12 months of primary study completion. Here is what sponsors should change—and one important detail about what is guidance versus law.
The UDI Is on the Device. If Nobody Captures It at the Point of Care, Much of the Value Disappears.
TGA publishes new guidance for hospitals implementing UDI across inventory, clinical systems, patient records and recalls.
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.
Canada Wants Data on 200 Chemicals. The Hard Part May Be Finding It Across Your Supply Chain
Canada launches mandatory CEPA section 71 reporting for 200 priority substances, with Phase 1 responses due March 3, 2027.
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.
The Software Updated Successfully – did the Patient’s Alarm Settings Survive?
FDA warns that GE Portrait software updates can remove monitored patients and reset alarm settings, creating a clinical change-control risk.
FDA finalizes type VII veterinary master file guidance
FDA’s Center for Veterinary Medicine finalized guidance in August 2026 explaining the use of Type VII Veterinary Master Files for research, development and certain risk reviews involving advanced veterinary technologies. The guidance is especially relevant to: The value is not simply a new file type. The important point is when…