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2020 OPDP Enforcement

Eye on FDA

Looking now to a review of enforcement by the Office of Prescription Drug Promotion (OPDP) in 2020, we see a different picture. The collection of letters issued by OPDP during 2020 can be found here. The article states that the program had received over 2000 reports over its lifetime. So when OPDP did act, they meant business.

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3 Ways to Boost Veterinary Pharmacy Revenue

epicur

Quick Facts: The veterinary compounding market is expected to increase from US$ 1.1 Bn in 2020 to over US$ 2.7 Quick Facts: The veterinary compounding market is expected to increase from US$ 1.1 Bn in 2020 to over US$ 2.7 Bn by 2031, expanding at a CAGR of around 8.5% Bn by 2031, expanding at a CAGR of around 8.5%

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NITROSAMINES: Where now?

European Pharmaceutical Review

2020 [cited 2023Jan]. 2020; 24(12): 2915-2926. 2020; 22(4): 89. Questions and Answers for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. EMA/409815/2020 Rev.13. 2020; 24(9): 1558–1585.

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Pharmaceutical industry: 2023 in retrospect

European Pharmaceutical Review

During 2023, there were five revisions to the European Medicines Agency ’s (EMA’s) Questions and Answers (Q&As) for marketing authorisation holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products. 02 October 2023 EMA/409815/2020 Rev.19.

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API nitrosamines: method sensitivity issues

European Pharmaceutical Review

Carcinogenicity data was then reviewed for structurally relevant nitrosamines and group-AIs were derived based on the most potent compound within each group. Procedure under Article 5(3) of Regulation EC (No) 726/2004. 25 June 2020. EMA/369136/2020. European Directorate for the Quality of Medicines & HealthCare.

Dosage 59
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Black Seed Oil and Hashimoto’s

The Thyroid Pharmacist

pylori flare back in 2020. This article will explain how black seed oil, which has grown in popularity in the medical world, may be a game changer and get you one step closer to putting Hashimoto’s into remission. In this article, you will learn: What is black seed oil?

Diabetes 116
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Reflecting on five years of quality control for nitrosamine impurities

European Pharmaceutical Review

This challenge is further compounded by increasingly complex drug formulations and global ingredient supply chains that stretch manufacturers’ capabilities in testing and control of impurities. 1 Nitrosamines are not new or unknown impurities. Control of Nitrosamine Impurities in Human Drugs – Guidance for Industry. cited 2023June].