The Premier Consulting Blog

NOVEMBER 16, 2022

Excipients are ingredients separate from a drug’s active pharmaceutical ingredient (or drug substance) that are added to products to impart various properties such as binders, fillers, solubilizers, carriers, and pH adjusters. Involving nonclinical/toxicology experts early on is key to reducing the package of studies as much as possible.

FDA 52

FDA Packaging Production Compliance 52

Agency IQ

JANUARY 26, 2024

Pharmacopeia (USP) and the FDA – to clarify whether the “actual ‘shelf life’ of many pharmaceutical products might be considerably longer than the expiration date that appears on the manufacturer’s container.” And per the FDA, “extension of drug product expiration dating periods is strictly voluntary for pharmaceutical manufacturers.”

Science 40

Science FDA Production Packaging 40

Codon

APRIL 9, 2024

However, the blandly clinical package of artemisinin and artesunate tablets reveals little about how the key compound was first discovered. It was only in 2005, after the emergence of widespread resistance of P. By 1971, more than 70 research institutions across a range of sectors joined the effort.

Drugs 126

Drugs Science Research Doctors 126

The Pharma Data

NOVEMBER 2, 2020

Oncopeptides is a pharmaceutical company focused on the development of targeted therapies for difficult-to-treat hematological diseases. Rein Piir, Head of Investor Relations at Oncopeptides, E-mail: rein.piir@oncopeptides.com. This information was submitted for publication at 8.00 CET on 3 November 2020. About Oncopeptides.

Marketing 40

Marketing Regulations Packaging Pharmaceutical Companies 40

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR. On September 14, 2018, the U.S.

Regulations 40

Regulations Compliance Production Government 40

Agency IQ

JUNE 16, 2023

This package would propose updates to the alternative work practice as appropriate based on the review and address the issues raised for reconsideration. Since promulgation, advancements have been made in leak detection technologies that warrant review of the alternative work practice. On September 14, 2018, the U.S.

Regulations 40

Regulations Compliance Production Science 40

Drug & Device Law

JULY 31, 2023

The 2005 revisions to Article 2 excludes “information” from the definition of goods and also defines computer software as “information.” Alaska 2005), predicted that Alaska would follow the Third Restatement “defin[ition] of a product as ‘tangible personal property distributed commercially for use or consumption.” Id. Munhoven v.

Production 52

Production International Trials Government 52