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Common pharma compliance concerns cited by FDA warning letters

European Pharmaceutical Review

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.

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Hikma shares rally after US launch of Advair generic resumes

pharmaphorum

Shares in Hikma have rallied as it resumed the launch of its generic Advair Diskus in the US, after clearing up a final piece of bureaucracy with the FDA. The amendment was required because of enhanced packaging controls to meet new industry standards adopted since the filing.

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Fixed-dose combination: Considerations for design, formulation, manufacturing and analysis

Pharmaceutical Technology

Pharmaceutical companies – and the FDA – are embracing FDCs. From 1990 through 2013, the FDA approved 131 FDC products, on average 5.7 Between 2010 and the end of 2015, of the 655 New Drug Applications (NDAs) approved by the FDA, 63 were for FDCs. Of those 131 approved FDCs, 98 were oral dosage forms.

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Case Study 2 – The Journey Leading to an Approved NDA

Impact Pharmaceutical Services

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.

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Case Study 2 – The Journey Leading to an Approved NDA

Impact Pharmaceutical Services

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.

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Methodology to Define a Pharma 4.0™ Roadmap

ISPE

The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. 13 May 2010. Methodology to Define a Pharma 4.0™ to Industry 4.0

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Nextstellis®: A new drug update 

Birth Control Pharmacist

new combined oral contraceptive was approved by the FDA (Nextstellis®) in April 2021. In conclusion, Nextstellis is a recent FDA-approved oral contraceptive that offers patients another alternative for birth control. Nextstellis (Drospirenone and Estetrol) [package insert]. 2010, pubmed.ncbi.nlm.nih.gov/21166370/.