European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 105

FDA Documentation Packaging Labelling 105

The Checkup by Singlecare

MAY 1, 2025

Food and Drug Administration (FDA) in 2010. Since 2010, Victoza has had more FDA approvals, including one in 2019, where it was approved for pediatric patients with type 2 diabetes. The most significant difference you will notice is the packaging and most importantly the price, said Dr. Turner.

Dosage 52

Dosage FDA Adverse Reactions Labelling 52

Druggist

JULY 27, 2020

Dosette box is composed of small sealable compartments, which hold tablets removed from blister packaging (original pack). Each box comes with a card/chart which contains dispensing labels and description of supplied drugs. Some drugs need to be kept in their original packaging due to (physiochemical) properties of the formulation.

Community Pharmacies 69

Community Pharmacies Packaging Medication Dispensing Labelling 69

Impact Pharmaceutical Services

AUGUST 9, 2022

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. Download a PDF of this case study. The Journey Leading to an Approved NDA.

Documentation 40

Documentation FDA Packaging Labelling 40

Impact Pharmaceutical Services

AUGUST 9, 2022

In 2010, following a referral from another company, IMPACT (now part of Syner-G BioPharma Group) was contacted by a mid-size biopharmaceutical company to assist them with an upcoming NDA for a new chemical entity in the treatment of an orphan condition. The Journey Leading to an Approved NDA. 5 clinical study reports.

Documentation 40

Documentation FDA Packaging Labelling 40

The Thyroid Pharmacist

SEPTEMBER 6, 2023

Personal Care : The Wellnesse line of haircare and toothpastes by Katie Wells (aka the “Wellness Mama”) contains high-quality, safe ingredients that are clearly labeled, so there are no surprises! They even have a trial package , so you can test their products out and see how they work for you! Published February 2, 2010.

Health and Personal Care Stores 94

Health and Personal Care Stores Packaging Compounding Labelling 94

Birth Control Pharmacist

SEPTEMBER 20, 2021

While not stated in the current package insert, data are emerging that support fewer breast tissue effects and breakthrough bleeding than older oral contraceptives. Nextstellis (Drospirenone and Estetrol) [package insert]. Available at: www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf. Accessed April 2021. .

Adverse Reactions 52

Adverse Reactions Packaging FDA Labelling 52