Fierce Pharma

FDA unveils 4th revision of draft guidance for looser biosimilar testing requirements

The FDA is doubling down on its goal to increase biosimilar drug availability in the U.S. | The FDA's newest draft guidance reinforces its previous commitment to streamlining biosimilar drug ...

ICH Stability Testing Requirements for Pharmaceutical and Supplement Products Explained

ICH stability chambers with continuous monitoring for long-term, intermediate, and accelerated studies supporting FDA ...
JD Supra

FDA Proposes to Overhaul Labeling Requirements for Approved or Conditionally Approved New Animal Drugs

Nearly five decades after the FDA last reorganized animal drug labeling regulations, the agency has released a proposal to revise the requirements for the content and format of labeling for approved ...
FedTech Magazine

FDA Tightens Its Medical Device Cybersecurity Guidance

Legacy medical devices face growing scrutiny as regulators push for stronger cybersecurity, transparency and risk management.
Food

FDA issues final rule on ‘healthy’ claim, updates requirements

The U.S. Food and Drug Administration (FDA) released its final ruling on requirements for the “healthy” nutrient claim, more than two years after initially proposing an update. Manufacturers must ...
JD Supra

FDA (Finally) Harmonizes Medical Device Manufacturing Requirements With ISO

On February 2, 2024, the US Food and Drug Administration (FDA) published a much-awaited final rule: the Quality Management System Regulation (QMSR). 1 By issuing this rule, FDA amended the medical ...
Agri-Pulse

FDA proposes to extend compliance dates for ag water testing

The Food and Drug Administration plans to extend the compliance deadline for pre-harvest water testing requirements for produce other than sprouts, the agency said in a proposal that also extends the ...

FDA Plans to Loosen Testing Rules to Boost Biosimilar Drugs

The US Food and Drug Administration is easing some requirements for drugmakers developing copycat versions of costly biologic ...
The Hill

FDA says new regulations are needed to manage CBD risks

The Food and Drug Administration (FDA) on Thursday called for new regulations for the cannabidiol (CBD) market, saying the agency needs to provide additional oversight to manage the risks involved in ...