European Pharmaceutical Review

NOVEMBER 14, 2023

In response to supply chain challenges, including shortages of critical glass vials for products like COVID-19 vaccines and parenteral drugs, the Packaging and Distribution Expert Committee (PD EC) has made a significant revision of United States Pharmacopeia (USP) General Chapter <660>—Glass.

Packaging 105

Packaging Vaccines Documentation FDA 105

IDStewardship

MAY 12, 2023

Review your schedule, elective options, and documentation responsibilities We have to start with the basics in order to adequately orient to future expectations. Not too say it is as dramatic as the latter part of that statement, but it is a definite narrowing.

Communication 130

Communication Documentation Vaccines 130

The Checkup by Singlecare

FEBRUARY 15, 2024

However, simply having a qualifying disability typically isn’t sufficient; the person also needs documentation from a medical professional that indicates that the service animal could improve or support his or her condition. To be eligible for a service dog , individuals must meet the ADA criteria for a mental or physical disability.

Health and Personal Care Stores 98

Health and Personal Care Stores Documentation Grocery Stores Hospitals 98

pharmaphorum

JANUARY 27, 2023

“We’ve almost got an opportunity to take it to the next level now, because we saw this with the collaboration with the COVID vaccine development and roll-out of the vaccination programme. What I’ve seen with patient centricity over the last few years is really a broadening of the definition,” Dr Mullen explained.

Pharmaceutical Companies 111

Pharmaceutical Companies Pharmaceutical Companies Vaccines Documentation 111

ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. Each risk profile category contains a definition with examples. Complete Data Gathering.

Vaccines 97

Vaccines Compounding Documentation FDA 97

The FDA Law Blog

SEPTEMBER 30, 2024

Another rejected proposal was a definition of “vaccine” (vaccines are exempt from Medicaid rebates), which would have limited this term to a product that is administered prophylactically – i.e., to prevent rather than treat a disease. Remarkably, manufacturers may not dispute a CMS notification. 1396r-8(k)(3).

Vaccines 59

Vaccines Packaging FDA Documentation 59

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. Under this definition, a regulatory authority need not adopt in totality any decision reached by another regulatory authority, but they make their own decision.

FDA 97

FDA Vaccines Documentation Dosage 97