article thumbnail

Why Are FDA Inspections So Ineffective and Disappointing?

The People's Pharmacy

The same was true of another of the company’s products, Delsam Pharma Artificial Eye Ointment , which the company voluntarily recalled shortly after. “The FDA said Global Pharma failed to use adequate, tamper-evident packaging and distributed the drugs without proper preservatives.”

FDA 72
article thumbnail

Twenty Women Leaders In Healthcare Industry

PharmaShots

In addition to serving as Associate Editor-in-Chief of the IEEE Open Access Journal of Circuits and Systems, she has been an Associate Editor of IEEE Transactions on Biomedical Circuits and Systems since 2008. Present company and time period: Pfizer (26 yrs.) LinkedIn Total experience: 26 yrs.

FDA 40
Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

Trending Sources

article thumbnail

Halting Europe’s essential medicines manufacturing exodus

European Pharmaceutical Review

This left pharmaceutical companies in Europe with no European API supply source, and only a few suppliers in Asia. The last paracetamol plant in Europe, closed in France in 2008 as it was no longer economically sustainable, marking the exit of paracetamol manufacturing from Europe.

article thumbnail

CMC Requirements for New Drug Registration in Latin America

ISPE

In an era when the world is accelerating the development of drugs and targeted medicines using innovative technologies, pharmaceutical companies still face registration hurdles for well-characterized molecules because of redundant or additional local regulatory requirements.

article thumbnail

A New Regulatory Approach to Drive Sustainable Medicines

ISPE

As such there’s a growing question of how the industry will improve the sustainability profile of its existing medicines and ensure that sustainability is designed into new medicines, such as products, with a reduced environmental risk, greener manufacturing technologies, and recyclable delivery systems and packaging. 9 December 2021.

article thumbnail

What to Keep in Your Integrative Medicine Cabinet

The Thyroid Pharmacist

Follow package instructions. Follow package directions for each supplement. Sleep issues: I like to recommend Epsom salt baths, which contain magnesium that is absorbed through the skin (1 cup of salts per tub – follow package instructions, and don’t overdo it!), 2008 Jul;93(7):2559-65. Exp Parasitol. 2021;220:108043.

article thumbnail

Quality first: How pharma can meet injectables demand while staying compliant

Pharmaceutical Technology

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. During the Covid-19 pandemic, large-scale vaccine production placed unprecedented demand on the parenteral packaging industry.