Dot Compliance

MAY 3, 2024

In the pharmaceutical industry, the importance of regulatory compliance extends beyond fulfilling legal obligations. Compliance can be streamlined with the help of an electronic quality management system (eQMS) that incorporates regulatory standards into every operational aspect of a pharmaceutical organization.

Pharmaceutical Industry 52

Pharmaceutical Industry Compliance Regulatory Compliance FDA 52

Bill of Health

JUNE 26, 2023

By Aparajita Lath For over 100 years, policy makers and pharmaceutical manufacturers in the U.S. have debated whether the government should produce drugs and biologics. Until now, private industry has largely won– but that may be changing, due to a recent California initiative. Now, the tide is turning.

Pharmaceutical Industry 190

Pharmaceutical Industry Governance FDA Public Health 190

Bill of Health

SEPTEMBER 12, 2023

By James René Jolin and Susannah Baruch On July 13, 2023, the United States Food and Drug Administration (FDA) approved Opill (norgestrel) as the first daily oral contraceptive available for non-prescription use in the U.S. James René Jolin (JRJ): This recent move by the FDA is one without precedent. It was a long time coming.

FDA 184

FDA Pharmaceutical Industry COVID-19 Public Health 184

Bill of Health

SEPTEMBER 28, 2023

Such a provision could prevent the public from paying twice for publicly-funded medical products—first through their taxes subsidizing government funded research and development, and second to procure the product in an inflated U.S. pharmaceutical market. Moreover, the NASDAQ Biotechnology Index increased by 374% from 1995 to 2000.

COVID-19 205

COVID-19 COVID-19 Vaccine Pharmaceutical Industry Governance 205

SQA

JULY 8, 2022

It is not intended to provide information on the terms and procedures directly associated with regulatory requirements governing cell-based products. 88, Microbial Data Deviation Investigations in the Pharmaceutical Industry, January 2022. However, it can provide general guidance during the assessment of regulatory requirements.

Pharmaceutical Industry 40

Pharmaceutical Industry FDA Hospitals World Health 40

SQA

AUGUST 2, 2021

This technical report focuses on the challenges facing the pharmaceutical industry that use complex packaging systems for sterile drugs and biologics (e.g., Led by the FDA and ASPR, the White House report and its recommendations ( report PDF ) have been accepted by President Biden. United States FDA – Guidances for Devices.

FDA 83

FDA COVID-19 Pharmaceutical Industry Hospitals 83

SQA

FEBRUARY 26, 2024

This standard is a globally recognized standard that provides guidelines for the governance and management of AI technologies. It provides a practical guide for the pharmaceutical industry on how to implement PACs within the framework of an effective Pharmaceutical Quality System (PQS) and in alignment with ICH quality guidelines.

FDA 52

FDA Compliance COVID-19 Public Health 52