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 we attended the Pharma Manufacturing World Summit 2023. In this interview, Geoff talked to Teresa about the latest developments in FDA regulations post-pandemic in the United States. They explored the […]
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 and facilities. That means cosmetics manufacturers must analyze their quality systems to identify gaps and ensure they are ready to implement any necessary changes to comply with the new law. […]
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 approval for these personalized medicines is intricate and multifaceted. With this new medical frontier, it is vital that we properly navigate the future of CAR T Cell Therapy and the […]
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 for the industry. Here are the key highlights and insights into the Final Proposed Rule of the ISO 31485-2016 harmonization. Highlights of the Proposed Rule Two-Year Compliance Period Industry stakeholders […]
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 There is a high degree of value in working closely with FDA from pre-clinical Development through Clinical Development to ensure successful PMA applications approval in a timely manner. FDA has taken many steps to increase […]
“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 to Accept Policy for 510(k)s”, is now available on fda.gov. Refuse to Accept Policy for 510(k)s This is an important Guidance document for all firms intending to file 510(k) s […]
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 substantially reducing the importance and significance of regulatory Guidance Documents for not only life sciences companies, but all industry segments. Although ironically the policy position was itself not effectuated 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 known for some time, FDA has been planning changes to their regulation and enforcement of dietary supplements. On 21 December 2015, the US Food and Drug Administration announced their new […]
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, in light of FDA’s new, final “Guidance for Industry on Circumstances That Constitute Delaying Denying Limiting or Refusing a Drug Inspection“, dated October 2014. The subject of the LinkedIn post […]
Sponsor Reporting of Falsified Data, A New FDA Proposed Rule
Today the FDA has published a proposed rule in the Federal Register (75 FR 33 at 7412, 2/19/10) that will require sponsors (and defining petitioners under food/supplement submission rules as sponsors) to report to FDA any instance of falsified data that the sponsor company identifies within a proposed or current human or animal study in […]
