pharmaphorum

JULY 28, 2022

Supply chain challenges are compounded by the broader global picture, such as the war in Ukraine, the great resignation, and natural disasters. That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. It can be done, of course, but it is costly.

FDA 110

FDA Dosage Documentation Compounding 110

Hospital Pharmacy Europe

DECEMBER 13, 2023

Notably, 50% of the new drugs approved by the FDA in 2022 were biologics , underscoring the magnitude of this transformation. This is because biologics tend to be much larger compounds, which are harder to absorb in the gut. Dosage is also an issue when it comes to delivery via inhalation.

Hospitals 98

Hospitals Dosage Compounding Vaccines 98

ISPE

MARCH 8, 2023

Identification and Analysis of Contamination Trends Three major recall databases—those of the US FDA, the United Kingdom’s Medicine and Healthcare Products Regulatory Agency (UK MHRA), and Australia’s Therapeutic Goods Administration (TGA)—were searched to assess contamination trends in the past five years.

Compounding 52

Compounding Compounding Pharmacies Packaging FDA 52

The Checkup by Singlecare

JANUARY 10, 2023

Besides the flu vaccine , which remains the best bet for the prevention of influenza and its complications , the other top way to fight back is the drug Tamiflu , an antiviral pill. Pharmacists can even compound a liquid form if needed using capsules. Two older adamantane antiviral drugs are also still in the picture. Savings options.

Dosage 52

Dosage Compounding FDA Immunization 52

ISPE

SEPTEMBER 11, 2023

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA.

Documentation 52

Documentation FDA Packaging Communication 52