Remove Licensing Remove Packaging Remove Pharmaceuticals
article thumbnail

Animals Need Drugs Too, But Not Without CVM Approval

FDA Law Blog: Biosimilars

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

Drugs 59
article thumbnail

Do You Have a Combination Product, and Is It Drug-led or Device-led? Early Regulatory Insights

The Premier Consulting Blog

e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., typical drug device, biologic device) Two or more separate components, co-packaged (e.g., e) reveals more detail — and gray areas: Two or more regulated components, in one package (e.g., Also see the FDA’s FAQs on this topic.)

Insiders

Sign Up for our Newsletter

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

article thumbnail

Scaling Phage Therapy

Codon

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. There is also a growing body of successful treatments in the U.S., 4 But the same barriers still exist today.

Therapies 125
article thumbnail

A Roadmap for Introducing Novel Excipients: How to Approach Excipient Qualification with the FDA

The Premier Consulting Blog

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs. What is an excipient?

FDA 52
article thumbnail

Tonix Pharmaceuticals Enrolls First Participant in the PRECISION Study, an Observational Study to Facilitate Development of Precision Medicine Techniques for COVID-19 Vaccines and Therapeutics

The Pharma Data

15, 2020 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. President and Chief Executive Officer of Tonix Pharmaceuticals. About Tonix Pharmaceuticals Holding Corp. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products.

Vaccine 40
article thumbnail

Q&A: The IND Journey Phase I – Navigating Success

Advarra

The sponsor is the pharmaceutical company conducting the trial. A: Working in a pharmaceutical company is the best way to learn this. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? A: This does not usually happen. Yes, each drug has its own requirements.

article thumbnail

Biopharma Money on the Move: December 2 – 8

The Pharma Data

The fully integrated pharmaceutical company creates value through China’s specialty pharmaceutical markets with focus on iron deficiency, pain management and respiratory. SciNeuro Pharmaceuticals . Already having been in clinical studies at Roche, all four candidates have strong clinical and preclinical safety packages.

RNA 52