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Dual Tracks Taken by FDA in Approving Products by ‘Big Pharma’

Prescription drugs exist to boost the health of patients by decreasing their pain, increasing their stamina, staving off infections and treating their symptoms. The U.S. Food and Drug Administration has the responsibility to...more

Questions About FDA’s Drug Approval Process Answered

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to...more

Amarin Pharma Comes Out on Top in Federal Case Involving Freedom of Speech

The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional...more

Big Pharma Should Take Reporting Adverse Events to FDA More Seriously

The U.S. Food and Drug Administration’s requirement that pharmaceutical companies report dangerous side effects cause by medicines they manufacture is being flouted by a few bad actors. Such violations of the federal law are...more

The Art of the Drug Ad

Television spots touting prescription medications have flooded the airwaves for nearly 20 years. During that time, pharmaceutical companies marketing their products have become surprisingly savvy at delivering the message....more

Federal Judge Remands Viagra Case to State Court

In February 2015, sixteen plaintiffs sued Pfizer, the maker of Viagra, alleging that their ingestion of Viagra between 1998 and 2013 caused them to develop melanoma. Plaintiffs asserted the following cause of actions: breach...more

FDA Approval of Addyi Sparks Debate

Is the controversial new drug touted as female Viagra cause for celebration or concern? Does the little pink pill represent “girl” power, or is it a shortsighted remedy for sexual dysfunction in women? Do its benefits...more

Xarelto Litigation Update – Jacksonville Filing

Brenda S. Fulmer, a 21-year veteran of drug and medical device litigation and a partner with Searcy Denney, filed an indivdual lawsuit against the manufacturers of Xarelto in federal court in Jacksonvillle this week. The case...more

Putting Testosterone to the Test

Testosterone is the new big drug on the market. Marketed to men with ow T, a vague illness with even vaguer symptoms, there has been a recent explosion in its use. In line with this explosion are also the vast amounts of ways...more

Public Citizen Wants Black Box on Testosterone Products

There appears to be no shortage of advertising for testosterone products for men to relieve low sex drive and fatigue. But these products remain without any warning on the product labels despite a recent study that showed the...more

Living off the Label

Doctors and physicians are given a great deal of discretion when it comes to prescribing drugs for uses other than those indicated by the FDA. This is known as “off-label” use. The FDA, realizing the danger of off-label...more

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