The FDA Law Blog

JUNE 21, 2023

As acknowledged in the Strategic Priorities document, certain demographic groups may have limited access to necessary treatments and diagnostics. FDA defines a Home Use Device as “a medical device intended for users in any environment outside of a professional healthcare facility. We previously blogged on the draft guidance here.

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ISPE

JULY 19, 2023

In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? and management communication strategy.

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Documentation FDA Labelling Communication 98

Pharmacy Times

JUNE 9, 2025

Pulmonary function tests and provider documentation were manually reviewed to confirm asthma diagnoses, while individuals with other pulmonary diseases were excluded. 1 The study also observed that 65% of patients had a documented visit with an asthma specialist during the follow-up period.

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Pharmacy Times

JUNE 20, 2025

Other documented causes of secondary dysmenorrhea include fibroids, adenomyosis, infection, myomas, obstructive reproductive tract anomalies, and ovarian cysts About the Author Yvette C. Dysmenorrhea, also known as painful menstruation, is the most commonly reported menstrual symptom among females during the reproductive years.

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ISPE

AUGUST 29, 2022

For changes requiring approval before implementation, once the necessary information has been submitted across regions, each health authority must review the data package and documentation based on local requirements. laboratory notebooks, batch records, and technical reports) to submission documents (e.g.,

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Documentation FDA Communication Packaging 52

Pharmacy Times

JUNE 17, 2025

During this time frame, the pharmacy documented 152 interventions. If a discrepancy is found, the pharmacy nurses will hold the shipment, and a clinical intervention will be communicated to the provider. Results American Oncology Network (AON) Pharmacy collected data on waste and cost avoidance from February 2023 to September 2023.

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Mail-Order Pharmacies Compounding Pharmacies Medical Records Dosage 65

ISPE

NOVEMBER 1, 2022

The first keynote speaker was Michael Kopcha, PhD, RPh, Director of the Office of Pharmaceutical Quality (OPQ), Center for Drug Evaluation and Research (CDER), US FDA. The US FDA monitors quality, and Kopcha traced changes in regulation of quality over the years. FDA Activities in Support of Quality. Tue, 11/01/2022 - 06:49.

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FDA Insurance Chemotherapy Documentation 98

The FDA Law Blog

JANUARY 2, 2025

By Ritte van Laack As we previously reported in 2022, FDA published a proposed rule defining the nutrient content claim healthy. FDA received more than 400 comments, resulting in a final rule published on December 27, 2024, covering more than 100 pages. The final rule maintains the concept of the proposed rule.

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FDA Labelling Documentation 52

The FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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Documentation FDA Labelling Communication 95

The FDA Law Blog

MAY 26, 2025

Hull & JP Ellison At our webinar earlier this month, we talked about Administration priorities as they relate to the FDC Act and noted that we expect much to remain the same with respect to enforcement. The gray box at the top of the document at this link shows the change in position. By Andrew J.

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Labelling HIPAA Documentation Pharmaceutical Companies 59