STAT

OCTOBER 23, 2024

Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. Novo has repeatedly argued that compounded products are risky, stressing that they are not approved by the FDA.

Compounding 263

Compounding Compounding Pharmacies Documentation Biosimilars 263

European Pharmaceutical Review

JULY 4, 2024

2 The prerequisite to present statistically significant evidence for having efficacies of clinical relevance is crucial because FDA requires “adequate and well-controlled” multicentre clinical studies on any new drug candidate to document and support its safety and efficacy, and imposes the maximum level of scrutiny prior to approval.

Drug Development 103

Drug Development Biosimilars Documentation Labelling 103

GMPSOP

JUNE 9, 2024

Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).

Method Validation 52

Method Validation Documentation Health and Personal Care Stores Labelling 52

Ramblings of a pharmacist

FEBRUARY 16, 2022

For example, “In the compounding period of 1941, the average pharmacy filled about 5,000 prescriptions a year, approximately 15 a day.” In both his 2011 article and his article from yesterday, he makes the same point “pharmacy gross profits remain stable,” - but the figure in 2009 was 23.8%

Independent Pharmacies 52

Independent Pharmacies Compounding Specialty Pharmacies Prescription Filling 52

PharmaTech

JUNE 23, 2025

Pharmacist weighing chemical | Image Credit: © Kzenon - stock.adobe.com Performing calculations for the formulation of pharmaceutical dosage forms and related preparations is a key activity in compounding. It builds on drug calculations topics previously described (1), including guidance documents (2–5). Pluta Nishant B. Active moiety.

Compounding 52

Compounding Dosage Labelling Drug Development 52

Putting Patients First Blog

JUNE 16, 2025

Developers should be required to: Conduct inclusive usability testing with older adults, people with disabilities, caregivers, and individuals with limited English proficiency; Share documentation of feedback collection and integration; and Comply with Section 508 and WCAG 2.1 Incentivizing the use of HL7 FHIR, OAuth 2.0,

Documentation 52

Documentation Communication Immunity Immunization 52

The Thyroid Pharmacist

DECEMBER 7, 2022

A few of the most common types of flame retardants include: Halogenated compounds (containing bromine and/or chlorine and known as polychlorinated biphenyls, polybrominated diphenyl ethers, etc.). Breast milk and in-utero transmission have also been documented as a means for exposure and concern. [13]. 2011 Jan;119(1):A11.

Health and Personal Care Stores 88

Health and Personal Care Stores Labelling Immunity Immunization 88