How a monograph, general notices, and general chapters relate to good manufacturing practices.

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Industry should improve the standards for detecting drug impurities.

Knowing Nitrosamine Risks

With many on-site visits on hold, FDA seeks alternatives

Inspections Remain Stalled

Topic

Shannon Parisotto, MBA, is the corporate senior vice president of Charles River Laboratories.

Articles

Accelerated drug development timelines must accommodate all crucial elements of nonclinical safety studies.  

Toxicology: Ensuring Drugs are Safe for People

Jennifer Putnam is AR&D supervisor II, Perrigo

Katherine L. Ullman is president, KLU Consulting, LLC

Priscilla Zawislak is global regulatory affairs advocacy manager, DuPont Nutrition & Biosciences

David Schoneker is president, Black Diamond Regulatory Consulting, LLC

George Collins is vice president, Vanderbilt Chemicals LLC. 

Douglas G. Muse is consultant—Compendial Affairs, Eli Lilly & Co.

Brian Carlin is director QbD/Regulatory, DFE Pharma US

Joseph Zeleznik is technical product manager, IMCD US

R. Christian Moreton, PhD, is vice-president of pharmaceutical sciences at Finnbrit Consulting and a member of Pharmaceutical Technology’s editorial advisory board.

Viewpoint: Continued dialogue among pharma stakeholders is needed to achieve consensus regarding excipient composition.


Understanding Concomitant Components in Pharmaceutical Excipients

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

The broader national strategy sets seven goals, some fairly general, such as building public trust, safely reopening schools and businesses, advancing racial and ethnic equity, and restoring US global leadership.

Biden Pandemic Plan Highlights Vaccine Access and Therapeutic Development

Since FDA authorization of two innovative mRNA vaccines to combat COVID-19 in late 2020, 30 million doses have been distributed, but only 4 million people were vaccinated in December 2020, and just 13 million have received shots so far. 

Vaccine Rollout Even Worse than Expected

As the Biden administration readies to take over the reigns of government, top administration officials continue to rush through new rules and decisions that appear to challenge the independence and effective operations of FDA. 

FDA Struggles to Fend Off Further Attacks from Trump Administration

The company is recalling one lot of Metformin HCl Extended Release Tablets, USP 750 mg (generic equivalent to Glucophage Tablets) because of nitrosamine impurities.

Nostrum Laboratories Expands Recall of Metformin HCl Extended Release Tablets

The draft guidance document offers developers of these treatments information regarding product development, preclinical testing, and clinical trial design.

FDA Gives Guidance on Gene Therapy for Neurodegenerative Diseases 

FDA puts applications on hold as the agency limits alternative oversight methods. 

FDA Inspection Shutdown Increasingly Delays Approvals

The vetting and authorizing of important new therapies remained productive in 2020, despite the need to devote considerable resources to dealing with COVID-19 related approvals and policies.

Despite Pandemic, FDA Ramps Up New Drug Approvals

EMA has chosen Panalgo's Instant Health Data (IHD) platform to enable rapid analyses of real-world data.

Quality Systems

Do Pharmacopoeias Inadvertently Facilitate Data Integrity Violations?

Knowing Nitrosamine Risks

Inspections Remain Stalled