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About us

People

Avv. Flavia Betti Tonini, PhD, Of Counsel Flavia Betti Tonini is an experienced attorney with a solid background in corporate law, compliance, criminal law, and...

Posted on 13th January 2023 by lcmm@melchionnalaw.com

About us

Mission and Values

Mission Melchionna PLLC is an indipendent law firm. Melchionna PLLC’s mission is to provide outstanding legal services and tax advice. We focus on building a relationship with...

Posted on 5th November 2019 by lcmm@melchionnalaw.com

About us

Melchionna PLLC, a law firm with a focus on business, corporate, tax, and IP law.

About us Melchionna PLLC represents and assists North American and European business clients in achieving their goals with sound legal advice and innovative solutions to current...

Posted on 18th February 2019 by lcmm@melchionnalaw.com

Food law

FDA – Drug Supply Chain Security

The FDA has recently finalized some regulations regarding the Drug Supply Chain Security Act (DSCSA). The goal is to help companies that operate in the pharmaceutical industry...

Posted on 11th February 2019 by iulia@plus972group.com

International tax

Tax Cuts and Jobs Act 2017

The Tax Cuts and Jobs Act (TCJA), aimed at reducing the US’s federal tax burdens, came into effect on January 1, 2018. The most important aspects of the TCJA concern the reduction...

Posted on 11th February 2019 by iulia@plus972group.com

M&A and corporate law

Arbitration Clauses in Labor Contracts: Renouncing Class Actions is Legitimate

On May 21, 2018 The Supreme Court of the United States established a relevant principle in terms of hourly compensation in labor contracts and alternative conflict resolution in...

Posted on 11th February 2019 by iulia@plus972group.com

Food law

The Food Safety Modernization Act, FSMA

The FSMA gives the Food and Drug Administration (“FDA”) authority to regulate food grown, harvested, or processed in the US or elsewhere. The FDA has the duty to better protect...

Posted on 12th January 2019 by iulia@plus972group.com

M&A and corporate law

Quadro Economico USA – il mercato delle M&A e’ in ripresa per le aziende medio piccole

I dati piu’ recenti pubblicati dal Bureau of Economic Analysis (BEA) registrano la solidità del quadro economico degli Stati Uniti, con un PIL che evidenzia, nel terzo trimestre...

Posted on 15th December 2018 by iulia@plus972group.com

Money laundering

FATF e Anti Money Laundering (AML) Regulations

Il Dodd-Frank Act e il JOBS Act (Jump Our Business Startups) richiedono alle societa’ target americane, come noto, una serie di disclosure finanziarie molto accurate. Sulla base...

Posted on 14th December 2018 by iulia@plus972group.com

M&A and corporate law

FIRRMA, Foreign Investment Risk Review Modernization Act: sara’ piu’ difficile investire negli USA in alcuni settori chiave

Per l’anno fiscale 2019 e’ stato introdotto il “National Defense Authorization Act”, che ha rinnovato ed ampliato i poteri della Commissione sugli investimenti stranieri negli...

Posted on 10th December 2018 by iulia@plus972group.com

International tax

Offshore Voluntary Disclosure Programs, (OVDP): A critical step in the movement towards transparency

In the last two decades, [After 1989, transparency and privacy became an increasingly topic of investigation and discussion among scholars and professionals. From 1989 to 2015 the...

Posted on 10th December 2017 by iulia@plus972group.com

Food law

“Food Revolution”. A growing opportunity for higher quality food

According to the most recent data, nearly two third of United States population is reportedly overweight or obese. However, there is a growing segment of the population which is...

Posted on 20th October 2016 by iulia@plus972group.com

Fashion law

How vulnerable is your trademark when it comes to cross border litigation?

Gucci and Guess have been fighting court battles since 2009 over a simple “G”. In 2012, the New York court ruled in favor of Gucci and ruled that Guess was guilty of copying four...

Posted on 14th October 2016 by iulia@plus972group.com

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Food law

FDA – Drug Supply Chain Security


iulia@plus972group.com
FDA – Drug Supply Chain Security
Posted on 11th February 2019 by iulia@plus972group.com

The FDA has recently finalized some regulations regarding the Drug Supply Chain Security Act (DSCSA). The goal is to help companies that operate in the pharmaceutical industry understand the new methods that will be adopted in order to comply with product chain and distribution legislation regarding the electronic identification of products.

The new mechanism will allow the FDA to protect consumers from purchasing pharmaceutical products that are counterfeit, stolen, contaminated or dangerous.

With a few exceptions, the pharmaceutical products must be equipped with the new, electronic identification by November 27, 2018.

The information provided here does not, and is not intended to, constitute legal advice but simply information for general purposes only and may not be the most up to date. Use of our website or any of its links or resources do not create an attorney-client relationship between the reader, user, or browser and the law firm. The views expressed at, or through, this site are those of the individual authors writing in their individual capacities only.

iulia@plus972group.com
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