Regulatory planning and development assessment encompass a coordinated suite of methodologies aimed at evaluating the impact, efficiency and equity of planning policies and regulatory interventions.

Biological products, or biologics, are large, complex molecules produced in living systems such as therapeutic proteins, antibodies, and gene- or cell-based therapies. Under the Public Health Service ...

Investors and developers scour the Southern California real estate market searching for opportunities to buy dated houses that they can demolish and replace with large, modern homes to sell for much ...

Daven Mody, Pharm.D., Appointed as Senior Vice President, Regulatory and Quality Bruno Gagnon, B.Pharm., M.Sc., Appointed as Senior Vice President, Clinical ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

In 2023, the FDA rejected a small pharmaceutical company's new drug application (NDA) with a Refusal-to-File (RTF) decision. This letter provided information on a range of issues within the submission ...

The Food and Drug Administration (FDA) defines regulatory science as the science of developing new tools, standards, and approaches to assess the safety, effectiveness, quality, toxicity, public ...

Seasoned biotech executive brings deep experience across clinical development, regulatory strategy, and corporate operations, ...

Written feedback from FDA pre-NDA meeting includes a recommendation to conduct a second Phase 3 trial to generate additional efficacy and safety data prior to NDA submission of brilaroxazine for the ...

Base Carbon Inc. (Cboe CA: BCBN) (OTCQX: BCBNF) with operations through its wholly-owned subsidiary, Base Carbon Capital ...

As electrification in the automotive industry becomes standard and the roll-out of software-defined vehicles (SDVs) gains extra mileage, technology complexity is becoming a key issue for the industry, ...