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Articles by Anthony Fanucci
FDA Resolves Semaglutide Shortage: Next Steps for Community Pharmacies, Telehealth Companies, and Other Providers | JD Supra
Now that the shortage of semaglutide injection products has been resolved, the Food and Drug Administration (FDA) will restrict third parties from compounding the drug. Our FDA/Food, Drug & Device and Health Care Groups have developed an initial checklist for providers to consider during the FDA’s enforcement discretion period.
Manufacturers Take Note: FDA Clarifies In-Process Sampling Under Section 211.110 | JD Supra
Our FDA/Food, Drug & Device Team reviews how new draft guidance from the Food and Drug Administration (FDA) can help manufacturers better understand requirements for drug product manufacturing.
FDA Issues Draft Guidance on Post-Warning Letter Meeting Requests Under GDUFA | JD Supra
On September 1, the Food and Drug Administration issued draft guidance for post-warning letter meeting requests under the Generic Drug User Fee Amendments. Our FDA Compliance & Enforcement Team outlines factors drug manufacturing facilities should consider when attempting this avenue for obtaining preliminary FDA feedback.
FDA Issues Notice on Identification, Assessment, and Control of Nitrosamine Drug Substance-Related Impurities and Requests Comments | JD Supra
Our FDA Compliance & Enforcement Team highlights key takeaways from the Food and Drug Administration’s notice identifying scientific and regulatory considerations for nitrosamine drug substance-related impurities (NDSRIs) in drug products.
Industry Needs to Better Prepare for Drug Supply Chain Compliance
The Food and Drug Administration headquarters in White Oak, Md. Photographer: Al Drago/CQ Roll Call By Brendan Carroll and Anthony Fanucci Jan. 10, 2023, 9:00 AM Alston & Bird attorneys say stakeholders need to better prepare for full implementation of the Drug Supply Chain Security Act. In light of uncertainty around industry readiness, they advise communicating early and often with trading partners, FDA counsel, and industry experts. Year 10 of implementation has finally arrived. By Nov.
Industry Needs to Better Prepare for Drug Supply Chain Compliance
The Food and Drug Administration headquarters in White Oak, Md. Photographer: Al Drago/CQ Roll Call By Brendan Carroll and Anthony Fanucci Jan. 10, 2023, 9:00 AM Alston & Bird attorneys say stakeholders need to better prepare for full implementation of the Drug Supply Chain Security Act. In light of uncertainty around industry readiness, they advise communicating early and often with trading partners, FDA counsel, and industry experts. Year 10 of implementation has finally arrived. By Nov.
Thanks to Puerto Rican Festival of New Jersey leaders in Vineland
As we look forward to the 51st annual Puerto Rican Festival, I want to take this opportunity to thank the Puerto Rican Festival organizers, the Vineland police and fire departments, City Council President Paul Spinelli, Councilman Al Vargas and all of the members of City Council, and the many city residents who were involved during conversations regarding the parade route.
Fanucci: Lots to talk about after 100 days as mayor
This week marks the milestone of my first 100 days in office as mayor of the City of Vineland. It has been a whirlwind of activity, as I have met with residents, business leaders, elected officials and members of various city departments to listen, learn and formulate plans of action. Some days are more eventful than others, but one thing is for sure: I love what I am doing and my passion for the city grows every day.
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