The FDA Approval Process

Food and Drug Administration (FDA)

The road toward Food and Drug Administration (FDA) approval begins long before the agency actually gets involved. The pharmaceutical company starts with its own laboratory research and animal trials. Later, it takes the first formal step in the FDA’s pharmaceutical approval process by submitting an investigational new drug (IND) application. The medical device approval process follows a similar path. The … Read More

Daniel Gallucci to Co-Chair Invokana Lawsuit Conference

Daniel Gallucci of NastLaw will be co-chairing the HarrisMartin MDL conference on November 30 in Charlotte, NC. The conference will cover the following litigation: Invokana Proton Pump Inhibitors Talcum Powder Xarelto Neil D. Overholtz of Aylstock, Witkin, Kreis & Overholtz, Michael M. Weinkowitz of Levin, Fishbein, Sedran & Berman, and Jeffrey S. Grand of Seeger Weiss will be co-chairing the … Read More

About the FDA

Food and Drug Administration (FDA)

What is the FDA? The Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services. The FDA has broad regulatory authority over not just food and drugs, but also biologics such as vaccines, medical devices, tobacco products, certain cosmetics, and some veterinary products. The agency was formed in 1906 and today employs … Read More

Dermatologic Drug Prices Rise 400% in Six Years

The recent uproar surrounding the prices of EpiPens has attracted the attention of the media, lawmakers, and lawyers around the country. EpiPen prices have risen over 600 percent in the past several years, for no apparent reason other than to pad the pockets of Mylan Pharmaceuticals. However, Mylan is not the only company that is raising prices on its drugs. … Read More

What Is the Difference Between a Class Action and a Mass Tort?

Clients frequently ask us if class action lawsuits and mass tort lawsuits are the same. They do share commonalities. For example, both involve a large number of individuals suing one or more defendants for causing harm like food poisoning from salmonella-tainted vegetables. Despite certain similarities, the two types of lawsuits are not the same. Continue reading to learn about the … Read More

Daniel Gallucci Presenting at Harris Martin MDL Conference

NastLaw attorney Daniel Gallucci will be speaking at the upcoming HarrisMartin MDL Conference on September 28th, 2016. Topics covered in the conference include: Talcum Powder Proton Pump Inhibitors ELIQUIS Essure Taxotere Roundup Mr. Gallucci will providing an update on the Proton Pump Inhibitor litigation along with Neil D. Overholtz of Aylstock, Witkin, Kreis and Overholtz. The conference will be chaired … Read More

General Motors Ignition Switch Litigation Resurrected

General Motors Ignition Switch

The Second Circuit of appeals ruled on Wednesday, July 13, that General Motors was not shielded from ignition switch liability because of their 2009 bankruptcy filings. This decision reverses a 2015 ruling by U.S. Bankruptcy Judge Robert Gerber that found that GM was protected from ignition switch lawsuits. This decision was described as a “major victory” for millions of individuals who were suing … Read More

Proton Pump Inhibitor Litigation Conference Recap

NastLaw was pleased to be a part of the HarrisMartin Proton Pump Inhibitors – Kidney Injury Litigation conference on June 15th, 2016. Daniel Gallucci of NastLaw co-chaired the event along with Neil Overholtz of Aylstock, Witkin, Kreis & Overholtz, and Paul Pennock of Weitz & Luxenberg. The conference was very well attended, showing a strong interest in the litigation from … Read More

What Is A Black Box Warning Label

Food and Drug Administration (FDA)

We often refer to “black box warning” labels when discussing the side effects of drugs. But what is a black box warning label? Why is it so important? A black box warning label is the strongest warning the Food and Drug Administration (FDA) can place on a drug. They make companies put black box warning labels on drugs that show … Read More

Tips For Safe Driving During The 100 Deadliest Days For Traffic Accidents

With Memorial Day approaching, we begin to gather to commemorate those who gave their lives while serving our country. This holiday marks the unofficial start of summer and the “100 deadliest days” for traffic accidents from Memorial Day weekend to Labor Day weekend. The rise in the number of cars on the road due to schools on recess raises the … Read More