STAT

JANUARY 7, 2025

As of last October, the agency had received more than 500 drug submissions with AI components going back to 2016, with a large number in the areas of oncology, neurology, and gastroenterology.   Most of the compounds came from commonly prescribed medications including antidepressants and statins.

Compounding 255

Compounding Documentation 255

Eye on FDA

AUGUST 2, 2022

There are two means of gaining insight into the agency’s thinking about regulatory issues related to promotional communications by pharmaceutical companies; one is through the issuance of guidance documents, the other is through enforcement. But when it comes to enforcement things have changed greatly over the years.

Communication 88

Communication Pharmaceutical Companies Pharmaceutical Companies Documentation 88

RX Note

JUNE 5, 2023

Workplace activity involves how healthcare workers use and handle the drug in the workplace - such as opening shipments, compounding, administering or cleaning up after use or spills. Oral hazardous drugs No crushing or compounding may be done in an unprotected environment. Consider having spill-response exercises or drills.

Compounding 52

Compounding Packaging Hospitals Chemotherapy 52

RX Note

NOVEMBER 13, 2023

Registered companies Governed under Companies Act 1965 (companies registered before 2017) or Companies Act 2016 (companies registered since 1 January 2017). Records and documentations should be kept and updated systematically as stipulated by the law. Regulated by Companies Commission of Malaysia ("Suruhanjaya Syarikat Malaysia", SSM).

Community Pharmacies 52

Community Pharmacies Health and Personal Care Stores Documentation Independent Pharmacies 52

Syner-G

SEPTEMBER 15, 2023

Nonetheless, their rising popularity – eight of the top 10 best-selling drugs internationally in 2016 were biologics – underscores their increasing importance. This documentation supports process control, and optimization, and serves as a regulatory record of reliability and repeatability.

Drug Development 59

Drug Development Documentation Process Improvement Compounding 59

European Pharmaceutical Review

JULY 4, 2024

2 It was first approved as Fulyzaq in December 2012 and in October 2016, Napo Pharmaceuticals launched the new brand, Mytesi. The intricate nature of botanical products further compounds the challenge, demanding a paradigm shift in regulatory interpretation and QC standards. 3 Is two too few? BMB Reports. 2017;50(3):111–6.

Drug Development 103

Drug Development Documentation Biosimilars Compounding 103

The Thyroid Pharmacist

JUNE 16, 2023

Black seed oil has likely been used as a medicinal herb for 3000 years or more, and its use has been documented in Ayurveda, Unani, Tibb, Siddha, and other systems of medicine. [4] Black seed oil also contains the antifungal compounds thymol and THQ. A 2016 study found that TQ was able to eradicate 96.8 2016; 16: 471.

Diabetes 116

Diabetes Dosage Compounding Immunity 116