The FDA Law Blog

OCTOBER 18, 2022

Amongst CDRH’s highest prioritized device guidance documents are final versions of the transition plans for medical devices that fall within enforcement policies or that were issued emergency use authorizations (EUAs) during Covid-19 public health emergency (PHE). They are also open to information to include in these guidance documents.

Documentation 52

Documentation FDA Labelling 52

The Checkup by Singlecare

APRIL 17, 2024

Mounjaro (tirzepatide) is an injectable medication prescribed for Type 2 diabetes mellitus, which some doctors may prescribe off-label for weight loss. Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them.

Insurance 98

Insurance Insurance Coverage Compounding Pharmacies Compounding 98

Druggist

FEBRUARY 17, 2021

Insect venoms (wasps) contain several allergens, which cause unpleasant symptoms, and in some cases, may cause an anaphylactic reaction (Moffitt, 2003). Most pharmacies sell hydrocortisone cream as ‘own’ label product or branded products, foe example HC45 Hydrocortisone cream. 2003 Nov;96(11):1073-9. Emerg Med J.

Compounding 98

Compounding Documentation Labelling 98

European Pharmaceutical Review

JULY 20, 2023

SoHO entities must implement a traceability system to unmistakably link each SoHO donor to their SoHO donation and to all documents, samples, SoHO preparations and SoHO entities that are associated with that SoHO from the point of collection to human application and outcome monitoring. Cited 2023Mar].

Labelling 75

Labelling Documentation Hospitals 75

ISPE

JULY 10, 2023

In sections where we applied ChatGPT for example cases, we indicate this as such: The question or remark from us is labeled as Authors. This so-called zero-shot approach has the strong advantage that no data must be labeled for the tailoring step and that the same model can be used for many different NLP applications.

Labelling 52

Labelling Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. 5 (2003): 395–413. van Dorp, and J. Managing Traceability Information in Manufacture.”

Chemotherapy 52

Chemotherapy Documentation Dosage Communication 52