The FDA Law Blog

OCTOBER 16, 2023

Gonzalez — The Wall Street Journal (WSJ) recently published a series of articles as part of its special report “What’s Ahead for Artificial Intelligence.” Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products.

Documentation 119

Documentation FDA 119

European Pharmaceutical Review

AUGUST 25, 2023

According to the EC, revision to the document has been made to reflect changes in regulatory and manufacturing environments. The document highlights that the revision should also consider related changes in other GMP chapters and annexes as well as in other regulatory documents. What is included in the new revision?

Documentation 95

Documentation 95

Hospital Pharmacy Europe

NOVEMBER 2, 2023

To support the documents, in spring 2024 the RPS will launch a Greener Pharmacy Toolkit, allowing pharmacies to self-accredit their sustainability status. A version of this article was originally published by our sister publication The Pharmacist.

Hospitals 52

Hospitals Community Pharmacies Documentation Communication 52

IDStewardship

APRIL 13, 2023

In this article an infectious diseases pharmacist with experience managing antimicrobial stewardship programs discusses antimicrobial stewardship regulatory standards Authored by: Timothy P. Gauthier, Pharm.D., difficile infection, adverse effects, antibiotic resistance, hospital costs, and hospital length of stay.

Hospitals 236

Hospitals Documentation Communication Patient Care 236

DiversifyRx

NOVEMBER 24, 2023

While DSCSA (the Drug Supply Chain Security Act) enforcement is postponed until November 2024, it is critical to move forward in becoming compliant sooner rather than later. If you think that doesn’t happen nowadays, here’s an article about recent counterfeit HIV medications. To achieve this, the U.S.

Independent Pharmacies 52

Independent Pharmacies Packaging Documentation FDA 52

ISPE

SEPTEMBER 8, 2023

This article offers highlights from the discussion. Whether it’s not documenting all the interventions during routine production so it is unknown how many should actually be done during a media fill or not trending interventions, the interventions performed during a media fill are not representative of the production process.

FDA 52

FDA Vaccines Documentation 52

ISPE

JULY 6, 2023

This article highlights the overall benefits and scope of Q13, as well as what we see as the next set of opportunities to further expand the adoption of CM across the globe. Q13 Training Materials Although the guidance document has been completed and was endorsed in January 2023, the work is not yet done.

Documentation 52

Documentation Dosage FDA Pharmaceutical Companies 52