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

European Pharmaceutical Review

FEBRUARY 23, 2023

11 Future methods are likely to require samples being collected, labelled, filtered and processed to obtain their spectra. Adv Appl Microbiol 2010; 70:153–186 Teng L, et al. Label-free, rapid and quantitative phenotyping of stress response in E. Eng Life Sci; 2010; 10:422–429 De Marchi S, et al. link] Huang WE, et al.

Labelling 121

Labelling Packaging 121

The Thyroid Pharmacist

MARCH 7, 2025

to fluoride in my tap water, to hidden mold in my home, to my shampoo and deodorant (have you ever read those labels?!), 10] Its not only found in obvious sources like plastic containers and packaging, but also in the lining of canned foods and drinks, receipts, toys, electronics, and household items.

Health and Personal Care Stores 60

Health and Personal Care Stores Labelling Immunization Packaging 60

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

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