Navigating FDA Regulations Post-Pandemic: Interesting Insights from Teresa Gorecki
We enjoyed our very own Teresa Gorecki, Practice Lead at Compliance Architects, speaking with Geoff Mix, Head of Content and Research for Executive Platforms, when
Navigating the Modernization of Cosmetics Regulation Act of 2022: A Decade of Evolution and Industry Impact
New requirements for cosmetic product manufacturers under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) are being phased in throughout 2024, affecting cosmetics products
Navigating the Future of CAR T Cell Therapy Development: Insights from FDA Guidance
Cell and gene therapies represent a new medical frontier, offering hope for treating rare, orphan, and challenging diseases. However, the journey from development to market
ISO 31485-2016 Exclusive Insight: How FDA Reshapes Medical Device Quality Guidelines
The highly anticipated FDA Decision on the Harmonization of the Medical Device Quality System Regulations with ISO 31485-2016 has been released, marking a significant development
PMA Applications: 3 Key Elements on the New FDA Guidance for Industry on Acceptance and Filing Review
FDA has Published a Guidance for Industry on Acceptance and Filing Review for PMA Applications Key elements of this Guidance FDA has not changed the
“Refuse to Accept Policy for 510(k)s”: Critical FDA Guidance
Our very own Teresa Gorecki took to LinkedIn earlier this afternoon to announce... A critical Guidance has been issued by FDA; the new Guidance, “Refuse
US DOJ’s Impact on Regulatory Guidance: Navigating Rare Uncertainty in FDA-Regulated Industries
On January 25, 2018, the United Stated Department of Justice under Attorney General Jeff Sessions reversed decades of accepted regulatory guidance for agency practice by
FDA Announces New Office of Dietary Supplement Programs (ODSP)
Opportunities and Risks for Dietary Supplement Companies for 2016 and Beyond 2015 is certainly ending with a bang. As many of us industry insiders have
Smile, You’re On FDA-Camera!
The following entry is an excerpt from a LinkedIn post that I responded to today. It pertains to FDA's authority to take photographs during inspections,