Remove FDA Remove Pharmaceutical manufacturing Remove Safety
article thumbnail

Should we be worried about pharma’s supply chain?

World of DTC Marketing

We need a 21st-century approach that puts patient safety first. The US Food and Drug Administration (FDA) believes the adulteration of heparin was an economically motivated act—a clear breach of the US pharmaceutical supply chain. In other words, money over safety. Can patients really be confident in pharma supply chains?

article thumbnail

FDA warning letters highlight data integrity issues

European Pharmaceutical Review

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US.

FDA 98
article thumbnail

Switzerland and US sign drug inspection agreement

European Pharmaceutical Review

Under the agreement with the Swiss Confederation (Switzerland), the Swiss Agency for Therapeutic Products (Swissmedic) and the US Food and Drug Administration (FDA) will be able to utilise each other’s GMP inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.

article thumbnail

FDA releases analysis on drug product quality in 2022

European Pharmaceutical Review

The Office of Pharmaceutical Quality (OPQ) in the US Food and Drug Administration (FDA)’s Center Pharmaceutical Quality for Drug Evaluation and Research (CDER) has released its 2022 annual report analysing drug manufacturers and their products. FDA’s sampling and testing programme found 892 of 1,552 product samples (57.5

article thumbnail

European authorities recognised for leading medicine regulatory oversight

European Pharmaceutical Review

The agencies holding this status have been approved and validated as compliant and committed to upholding the “highest level of regulatory standards and practices for quality, safety and efficacy of medicines and vaccines ”.

article thumbnail

Regulatory Compliance: Ensuring that pharmaceutical products meet all regulatory requirements and guidelines, including safety, efficacy, labelling, and post-marketing surveillance

eMediWrite

Central Drugs Standard Control Organisation (earlier known as Drugs Controller General of India) are essential to the pharmaceutical production process. They play a crucial role in assuring the efficacy and safety of products given to patients. A company’s systems transparency may also be shown by such data.

article thumbnail

FDA completes inspection of Nexus’ manufacturing facility in US

Pharma Leaders

The Food and Drug Administration (FDA) has successfully inspected Nexus Pharmaceuticalspharmaceutical manufacturing facility located in Pleasant Prairie, Wisconsin, US. The inspection will allow the company to commence commercial operations at the three-storey, 84,000ft² manufacturing facility.