article thumbnail

In Uncertain Times, Good Compliance and Quality Communication Habits Can Offer a Port in the Storm

FDA Law Blog: Biosimilars

Claud The ongoing DOGE-led reductions to the federal workforce and recent sweeping policy changes have spawned many questions for compliance officers and quality managers in FDA-regulated companies. So, yes, compliance and quality still matter, a lot. By John W.M. How will the cuts at FDA impact inspections and enforcement?

article thumbnail

How to Identify Branded Drugs with a Low Likelihood of Generic Entry as Targets for In-Licensing

Drug Patent Watch

Case Study 2: Novel Formulation of Existing Drug A biotech firm discovered a branded drug with a novel formulation that significantly improved patient compliance. Biosimilars and Complex Generics The rise of biosimilars and complex generics is changing the dynamics of market exclusivity.

Insiders

Sign Up for our Newsletter

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

article thumbnail

Bio-Techne Joins Forces with USP to Speed Up Development of mAbs and Gene Therapies

The Pharma Data

By combining USP’s rigorously characterized reference materials with Bio-Techne’s user-friendly, high-resolution analytical instruments, the collaboration intends to streamline workflows, improve data accuracy, and enable greater compliance with global regulatory expectations.

article thumbnail

HP&M Welcomes Peter Dickos to the Firm

FDA Law Blog: Biosimilars

Pete’s in-depth knowledge of FDA’s internal processes and priorities enhances his ability to advise pharmaceutical, biotech, and other FDA-regulated companies on regulatory compliance, product development, and enforcement risk. He also provides strategic litigation support and proactive counsel on agency engagement.

article thumbnail

Addressing supply chain challenges for biosimilar products

Drug Patent Watch

Navigating the Complex World of Biosimilar Supply Chains As the demand for biosimilars continues to grow, so do the challenges associated with their supply chains. One of the biggest hurdles biosimilar manufacturers face is the need to replicate complex biological processes with precision and consistency.

article thumbnail

HP&M Seeks Experienced Regulatory Expert

FDA Law Blog: Biosimilars

Specifically, manufacturing/testing procedures and compliance with cGMPs. Conducting internal investigations and audits of manufacturing facilities for compliance with 21 CFR 211/600. Preparing for and responding to government inspections and other compliance matters.

article thumbnail

Building the requisite clinical development infrastructure for medical innovation to thrive

Drug Target Review

By investing in streamlined systems that create a single version of truth for aggregating, managing and analysing data, biotech firms can ensure compliance with regulatory requirements, increase efficiency, and potentially reduce overall clinical development time.