by Pill Pals | Oct 30, 2024 | News
Docket Number: FDA-2023-D-0093 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research This guideline is intended to provide recommendations on conducting bioequivalence (BE) studies 4 during both development and post approval phases for orally...
by Pill Pals | Oct 30, 2024 | News
FDA is reminding compounders to only produce sterile drugs using components that are suitable for compounding drugs intended to be sterile. The agency is aware of compounders using food-grade nicotinamide adenine dinucleotide (NAD+) sold by repackagers to make...
by Pill Pals | Oct 30, 2024 | News
Quality Matters Related to Components of a Drug FDA continues to identify several issues related to repackagers of bulk drug substances, also called active pharmaceutical ingredients (APIs), and excipients used to compound drugs that have resulted in patient harm. ...
by Pill Pals | Oct 30, 2024 | News
October 29, 2024 Summary of the Issue: The Food and Drug Administration is advising the public, including consumers, health care professionals, and community-based organizations, health departments, and clinics where HIV self-testing programs are available, that HIV...
by Pill Pals | Oct 29, 2024 | News
Delivery Method: VIA UPS Reference #: 320-25-07 Product: Drugs Recipient: Recipient Name Mr. Yucel Teker Recipient Title General Manager/Chairman of the Board MedOffice Saglik Endustri Anonim Sirketi Ic Kapi No. 1, No. 9-1 Yazibasi Mahallesi, Kuscu Caddesi35880...
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