The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. The final guidance focuses on labeling as a means to effectuate Criterion 4. software or labeling.

FDA 52

FDA Labelling Documentation Communication 52

ISPE

OCTOBER 27, 2022

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources. Calculates insulin dose based on a proprietary algorithm that incorporates. IMDRF SaMD Risk Categorization. Framework 26.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA Communication Clinic Management 52

ISPE

OCTOBER 27, 2022

The COVID-19 pandemic underscores the importance of DHTs through the increased reliance on telemedicine services and remote patient monitoring programs to ensure patient safety and triage scarce hospital resources. Calculates insulin dose based on a proprietary algorithm that incorporates. IMDRF SaMD Risk Categorization. Framework 26.

Health and Personal Care Stores 52

Health and Personal Care Stores FDA HIPAA Communication 52

Omnicell

JANUARY 10, 2023

When you consider that the OR accounts for 40% of hospital expenses and 70% of revenue , why wouldn’t you want optimal medication management in such a critical area? We’ve developed closed-loop functionality that makes it easier for providers to document waste, improving the likelihood of compliance.

Controlled Substances 52

Controlled Substances Omnicell Medication Dispensing Documentation 52

pharmaphorum

MARCH 2, 2021

The data must be quickly documented and reported to public health agencies to ensure effective record keeping, equal access to the vaccine and patient safety. After collecting the information, they print a plastic barcode label that can send the recipient’s vaccination records to the cloud with a simple scan. Vaccine supply levels.

Vaccines 119

Vaccines Adverse Reactions Documentation Labelling 119

pharmaphorum

FEBRUARY 2, 2021

“The vaccine is 100% effective in preventing serious disease or death, which in the end is the most crucial parameter; we can all deal with the sniffles as long as we stay out of the hospital or the graveyard,” said Hildegund Ertl of the Wistar Institute in Philadelphia, US.

Vaccines 75

Vaccines Documentation Labelling Hospitals 75

pharmaphorum

JANUARY 21, 2021

It can be prescribed in combination with methotrexate or as a monotherapy if the patient isn’t able to receive methotrexate, according to the final appraisal document (FAD). Having moderate disease on the label means that thousands more patients will be eligible for treatment with Jyseleca, according to Gilead and Galapagos.

Documentation 52

Documentation Labelling FDA Hospitals 52

The FDA Law Blog

FEBRUARY 22, 2023

All this time, FDA has applied the requirement for HF data to a subset of device types that pose the highest usability‑relate risks, e.g. , software controlled devices, some hospital devices, and home use devices. as a de novo special control or in a guidance document for a specific device type). 9, 2022).

FDA 64

FDA Documentation Labelling Hospitals 64

European Pharmaceutical Review

JULY 20, 2023

In addition to hospitals and blood transfusion centres, pharmaceutical, device and other companies involved with blood products and cell- and gene-therapy products are advised to closely monitor developments surrounding the proposed regulation. Strict requirements apply, especially with regard to traceability and coding.

Labelling 63

Labelling Documentation Hospitals 63

The Thyroid Pharmacist

JULY 14, 2023

Individual doctors may still be able to utilize this therapy with their patients as an “off-label” use. Remission of Hashimoto’s thyroiditis in a twelve-year-old girl with thyroid changes documented by ultrasonography. As much more research has come out, it appears that LLLT therapy is useful, non-invasive, and generally safe.

Dosage 97

Dosage FDA Immunization Documentation 97

The Thyroid Pharmacist

JULY 29, 2022

Perhaps more concerning, of the 133 different VOCs found across all tested products, only one, ethanol, was actually listed on any label! (13, For sunscreens and other over-the-counter drugs, fragrances must be identified on the label. But formaldehyde has been labeled as a known human carcinogen by the U.S.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies.

Documentation 97

Documentation FDA Hospitals Dosage 97