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

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Packaging Production 40

Agency IQ

DECEMBER 15, 2023

The 174 regulations the EPA is currently working on The Environmental Protection Agency has unveiled its Fall 2023 Unified Agenda, which provides a look into the agency’s regulatory agenda for the upcoming year. The expected release dates of the agendas rarely line up exactly with the actual dates when the agency releases the regulation.

Regulations 40

Regulations Compliance Production Government 40

The Pharma Data

NOVEMBER 2, 2020

To this end, the Board of Directors shall be entitled to make adjustments to meet foreign regulations or market conditions, including resolving on cash or other settlement if deemed favorable for Oncopeptides based on foreign tax regulations. Rein Piir, Head of Investor Relations at Oncopeptides, E-mail: rein.piir@oncopeptides.com.

Marketing 40

Marketing Regulations Packaging Pharmaceutical Companies 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. This information would be used in considering the regulation of asbestos.

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.” 2003), an Internal Revenue Service regulation, excluded liability for “product” refund, repair or replacement. Medicis Pharmaceutical Corp. , City of Madera , 2005 WL 1683736, at *13 (E.D.

Production 52

Production International Trials Government 52