article thumbnail

Using FDA Product Specific Guidances (PSGs) as a Trigger for Generic Drug Development

Drug Patent Watch

These guidances serve as a roadmap for companies looking to develop generic versions of brand-name drugs, offering invaluable insights into the FDA’s expectations for demonstrating bioequivalence and ensuring product quality. Understanding FDA Product Specific Guidances Product Specific Guidances are documents issued by the U.S.

article thumbnail

The Great RIF(T): One FDA Division’s Destruction and What it Could Mean for Generic Drugs

FDA Law Blog: Biosimilars

Indeed, since 2014, DPD facilitatedthe publication of 42 quarterly batches and dozens of stand-alone PSGs, plus three one-off batches of PSGs updated to align with recommendations in general guidance documents ( g. , Leading FDAs implementationof the Drug Competition Action Plan (DCAP).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Reports Document FDA Review Delays: What Drugmakers Should Know Now

FDA Law Blog: Biosimilars

One area drawing increasing attention is how these changes will affect the drug development and review process. As reported by the Wall Street Journal last week , reviews of both innovative and follow-on drugs have been caught in a traffic jam, largely due to a leadership vacuum at the Center for Drug Evaluation and Research (CDER).

article thumbnail

How CDMOs Can Help with Regulatory Challenges

Drug Patent Watch

They can help ensure that these submissions are complete, accurate, and timely, which is critical for advancing drug development programs. They can help ensure that the commercial pharmaceutical manufacturing process is designed to meet regulatory requirements and offer insight into the most effective manufacturing strategies.

article thumbnail

Are generalist investors good or bad for biotech?

STAT

Also, we see more documents destroyed at an Indian drug manufacturing plant, and offer up a fabulous podcast.   Sign up  to get our biotech newsletter in your inbox. Good morning! Today, we see Ginkgo pivot into AI, becoming yet another contender in a crowded market. Read the rest…

article thumbnail

Driving QbD as a quality standard in drug development

European Pharmaceutical Review

Over the past several years, the pharmaceutical industry has faced challenges regarding quality assurance in drug development, the author asserted. It also lowers the regulatory burden too, the paper reported. [In

article thumbnail

STAT+: ‘A cascade of failures’: FDA cites Indian drugmaker for numerous quality control problems

STAT

In a stunning rebuke, the Food and Drug Administration accused a drugmaker of a “cascade of failures” for a litany of quality-control problems at a manufacturing plant, the latest instance in which the regulator has castigated an Indian pharmaceutical company for such lapses.