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ARTICLES
What we know about Postpartum Depression (PPD)
04-Sep-2018

Postpartum Depression (PPD) is a serious mood disorder. It is estimated that, in the United States, depending on states, the incidence varies from 10 – 20%. PPD poses serious risk to the mother and the new born. PPD IS A MAJOR CAUSE OF MATERNAL MORTALITY. It affects maternal functioning and causes significant risk to the cognitive, behavioral and physical development of the infant and siblings. 

Currently the standard of care for PPD is the same treatment that is offered to manage Major Depressive disorder. Although SSRI are effective for Major depressive disorder, but it is not approved specifically for PPD. Therefore, there is a huge need for finding effective treatment for postpartum depression. 

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Statement from FDA Commissioner Scott Gottlieb, M.D., on significant public health value and cost savings resulting from the agency’s youth smoking prevention campaign
21-Aug-2018

One of the most important ways the U.S. Food and Drug Administration can reduce the disease and death caused by tobacco use is by preventing current and future generations of kids from starting down a path of a lifelong addiction to tobacco. This work includes exploring clear and meaningful measures to make tobacco products less toxic, appealing and addictive; enforcing federal youth access restrictions; and educating our nation’s youth about the dangers of tobacco use.

As part of the agency’s comprehensive plan on tobacco and nicotine regulation announced last summer, we’re taking steps toward a world where combustible cigarettes would no longer create or sustain addiction – making it harder ...

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Statement from FDA Commissioner Scott Gottlieb, M.D., on advancing the science and regulation of live microbiome-based products used to prevent, treat, or cure diseases in humans
21-Aug-2018

Over the last several years, there’s been growing scientific and public interest in the role of microorganisms in the maintenance of overall health and prevention and treatment of disease. Today, more so than ever before, consumers are familiar with the phrase “good” or “helpful” bacteria and the expectation that it will aid in treating or preventing various illnesses. As the field advances, the U.S. Food and Drug Administration is playing a key role in sorting through the science and the science fiction of this evolving field.

We know that certain medical issues, such as bacterial infections and their treatment with antibiotics, may disrupt the normal complement of microorganisms that naturally ...

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FDA approves first generic version of EpiPen
21-Aug-2018

The U.S. Food and Drug Administration today approved the first generic version of EpiPen and EpiPen Jr (epinephrine) auto-injector for the emergency treatment of allergic reactions, including those that are life-threatening (anaphylaxis), in adults and pediatric patients who weigh more than 33 pounds. Teva Pharmaceuticals USA gained approval to market its generic epinephrine auto-injector in 0.3 mg and 0.15 mg strengths.

“Today’s approval of the first generic version of the most-widely prescribed epinephrine auto-injector in the U.S. is part of our longstanding commitment to advance access to lower cost, safe and effective generic alternatives once patents and other exclusivities no longer prevent approval,” said FDA Commissioner Scott Gottlieb, M.D. “This approval means ...

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FDA permits marketing of transcranial magnetic stimulation for treatment of obsessive compulsive disorder
21-Aug-2018

Today, the U.S. Food and Drug Administration permitted marketing of the Brainsway Deep Transcranial Magnetic Stimulation System for treatment of obsessive compulsive disorder (OCD).

“Transcranial magnetic stimulation has shown its potential to help patients suffering from depression and headaches,” said Carlos Peña, Ph.D., M.S., director of the Division of Neurological and Physical Medicine Devices in the FDA’s Center for Devices and Radiological Health. “With today’s marketing authorization, patients with OCD who have not responded to traditional treatments now have another option.”

OCD is a common, chronic and long-lasting disorder in which a person has uncontrollable, reoccurring thoughts and behaviors that a person ...

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