Regulatory & Compliance

FDA Approves Etcamah for Resistant Metastatic Breast Cancer
Research & Development FDA Approves Etcamah for Resistant Metastatic Breast Cancer

In the United States, 300,000 new cases of breast cancer are diagnosed annually, many of which will eventually progress to a more resistant metastatic state. For patients facing these advanced stages, the traditional arsenal of chemotherapy and hormonal blockers often loses its efficacy over time,

Why Is Integrated CMC Key to Pharmaceutical Development?
Management & Regulatory Why Is Integrated CMC Key to Pharmaceutical Development?

Modern pharmaceutical development frequently stalls when chemists deliver a bulk powder that formulation scientists cannot effectively process into a stable dosage form. This persistent challenge is largely a relic of outdated, siloed organizational structures where drug substance synthesis and

Cybersecurity Crises Threaten the Global Healthcare Sector
Management & Regulatory Cybersecurity Crises Threaten the Global Healthcare Sector

Traditional views of Information Technology as an ancillary back-office function are being rejected in favor of a clinical care model. The healthcare sector has reached a tipping point where a network failure is now as critical as a power outage in an intensive care unit. Recent breaches at

Fort Wayne Medical Settles 2024 Data Breach Lawsuit
Management & Regulatory Fort Wayne Medical Settles 2024 Data Breach Lawsuit

Documentation such as bank statements or receipts is required for those seeking to recover up to $500 in ordinary expenses related to credit monitoring and identity fees. This requirement stems from the final resolution of a class-action lawsuit against the Fort Wayne Medical Education Program

Industry Leaders Urge FDA to Expand Prior Knowledge Guidance
Research & Development Industry Leaders Urge FDA to Expand Prior Knowledge Guidance

Industry groups are requesting concrete examples of how prior clinical data can be used to optimize dosing and streamline trial designs for rare disease therapies. This collective push follows the release of the Food and Drug Administration's draft guidance concerning the use of prior knowledge in

Why Is the FTC Suing Hims & Hers Over Patient Privacy?
Management & Regulatory Why Is the FTC Suing Hims & Hers Over Patient Privacy?

The FTC's complaint details how users were allegedly billed for prescription subscriptions almost instantly, often before a licensed healthcare professional had even reviewed their medical intake forms. This aggressive legal action, filed in July 2026, represents a coordinated effort by the Federal

Loading

Subscribe to our weekly news digest.

Join now and become a part of our fast-growing community.

Invalid Email Address
Thanks for Subscribing!
We'll be sending you our best soon!
Something went wrong, please try again later