Express Pharma

SEPTEMBER 19, 2024

These three co-located trade fairs bring together a wide array of technologies under one roof, covering the entire spectrum of laboratory technology, life sciences, pharmaceuticals, and packaging.  There will be case study presentations on CAPA, precision lighting, ergonomic seating in classrooms, and building operational excellence.

Packaging 105

Packaging Documentation 105

FDA Law Blog: Biosimilars

FEBRUARY 21, 2024

Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. includes considerations with respect to documentation, applicable regulatory requirements, design and development, and enforcement.

Labelling 57

Labelling Packaging Documentation 57

National Association of Boards of Pharmacy

JULY 19, 2024

On June 12, 2024, Food and Drug Administration (FDA) issued exemptions for certain dispensers and in limited scenarios, their trading partners, from certain requirements of section 582 under the Food Drug and Cosmetic Act (FD&C Act) until November 27, 2026. Gathering transaction information for recalls at the package level.

Pharmacy Technician 45

Pharmacy Technician Documentation Communication Packaging 45

Quality Matters

NOVEMBER 5, 2024

API DMFs are documents containing information on APIs that are submitted to the U.S. Food and Drug Administration (FDA) by API manufacturers to provide confidential, detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of human drug products.

Pharmaceutical Manufacturing 75

Pharmaceutical Manufacturing Packaging Documentation 75

Express Pharma

MAY 31, 2024

The industry is poised for sustained growth and is expected to reach $65 billion in 2024 with forecasts pointing toward a remarkable growth of around $139 billion by 2024 and $450 billion by 2047. This process involves mixing the ingredients, processing them, and then packaging the final product. Source: EY).

Pharmaceutical Companies 95

Pharmaceutical Companies Pharmaceutical Companies Vaccines Packaging 95

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Despite the removal of some of the most controversial proposals, the final rule still contains a variety of significant changes, which become effective on November 19, 2024. The term “drug product information” is now defined to include NDC, drug name, units per package size (UPPS), drug category (S, I, or N), unit type (e.g.,

Vaccines 57

Vaccines Inpatient Packaging Documentation 57

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

Putting Patients First Blog

MARCH 18, 2024

Additionally, incorporating beneficiary feedback and pilot testing of revised Evidence of Coverage documents can ensure that MPPP information clarifies rather than complicates coverage understanding. For the Annual Notice of Change, accessible language that accommodates varied health literacy levels is vital.

Insurance Coverage and Processing 40

Insurance Coverage and Processing Communication Documentation Mail-Order Pharmacies 40

PharmaShots

JUNE 1, 2023

These new results reinforce our differentiating data package for PDC*lung01. Eric Halioua: We forecast to get the final report of the current clinical trial (P-I/II PDC-LUNG-101 trial) in Q2 2024. Smriti: Please share the development timeline for the PDC*lung01, when can we expect the next phase of development?

Immunity 40

Immunity Immunization Vaccines Health and Personal Care Stores 40

Pharmacy Friday Pearls

AUGUST 29, 2022

mmol/L) There was no documented blood glucose concentration <100 mg/dL recording during the first 12 hrs of HIET. Insulin [Lexi-drugs] Dextrose injection package insert High dose insulin therapy. Intensive care medicine , 33 (11), 2019–2024. Greene et al., Potassium was maintained within low normal range (3.8-4.0

Packaging 52

Packaging Documentation 52