Content about Food and Drug Administration

October 10, 2013

One of the Food and Drug Administration's top regulators is not retiring, contrary to rumors reported in news media Thursday.

October 10, 2013

For the Food and Drug Administration’s Office of Generic Drugs, one of the biggest stumbling blocks has been its significant backlog of generic drug approval applications. But it’s steadily making progress in addressing the problem.

October 10, 2013

While the boom in generic drugs now looks set to wane, another segment of the pharmaceutical industry is rapidly rising and presenting new growth opportunities for pharmacy retailers: specialty drugs.

October 9, 2013

The Food and Drug Administration today approved Adempas, also known as riociguat, to treat adults with two forms of pulmonary hypertension, which is caused by abnormally high blood pressure in the arteries of the lungs.

October 9, 2013

A new law in Maine will allow consumers to purchase drugs by mail order from some pharmacies overseas, according to published reports.

October 8, 2013

A Republican congressman from Alabama has proposed a stopgap bill that would fund the Food and Drug Administration through the middle of December or until the government shutdown ends, though it is unlikely to pass in the Senate.

October 8, 2013

The Food and Drug Administration has approved a new treatment for hot flashes and the prevention of osteoporosis, the agency said.

October 8, 2013

Sales of professional aesthetic products climbed 7.5% in 2012, and given the growth, aesthetic devices manufacturers are becoming increasingly interested in expanding their direct reach into the consumer market by launching devices for at-home use, according to recent research by consulting and research firm Kline & Co.

October 7, 2013

An analysis by the New York Times published over the weekend makes the case for generic drugs.

October 3, 2013

The Food and Drug Administration is requiring Johnson & Johnson to use long-lasting ink in the labeling and dosage strength of an opioid painkiller patch it markets in order to make it easier to see.

October 1, 2013

The Food and Drug Administration has approved a new drug developed by Takeda to treat major depressive disorder, the agency said.

September 30, 2013

Amneal Pharmaceuticals has bought rights to four generic drugs from Actavis, Amneal said Monday.

September 30, 2013

The Food and Drug Administration has approved a drug for treating early-stage breast cancer before surgery, the agency said Monday.

September 30, 2013

The Food and Drug Administration has approved a new usage for a drug made by UCB, the drug maker said Monday.

September 27, 2013

Congress is expected to pass the Drug Quality and Security Act, which would subject sterile compounding pharmacies to stronger federal regulations and has attracted support from an independent pharmacy trade group, compared with a previous effort at federal regulations of compounding, Senate Bill 959, which many pharmacists feared would threaten their businesses and patients' access to compounded drugs. The efforts to place compounding pharmacies under federal regulations stem from last year's scandal in which many patients died and more were sickened after taking injected steroids contaminated with fungus.

The bills' purpose is simple enough: protecting the safety of patients by preventing irresponsible pharmacies like the New England Compounding Center from slipping through the cracks. But the older bill attracted opposition from independent pharmacies because, despite its good intentions, forced them to make costly changes to their business models or force them out of compounding altogether.

September 26, 2013

Legislation to allow the Food and Drug Administration to strengthen its regulatory powers over compounding pharmacies is expected to pass both houses of Congress after committees agreed on it Thursday, according to published reports.

September 25, 2013

Foods must carry gluten content of less than 20 parts per million in order to carry the label "gluten-free," according to a new regulation issued by the Food and Drug Administration.

September 25, 2013

Mylan is challenging the patent protection on a drug used to treat fibromyalgia, prompting a lawsuit from the branded drug's manufacturers.

September 24, 2013

The Food and Drug Administration has approved a new dosage strength for a chronic pain patch made by Purdue Pharma, the drug maker said Tuesday.

September 23, 2013

The Food and Drug Administration has approved a drug made by Johnson & Johnson for psoriatic arthritis, the company said Monday.

September 23, 2013

The Food and Drug Administration has approved a drug made by Perrigo Co. for treating heart disease, the company said Monday.

September 23, 2013

The Food and Drug Administration will not enforce regulatory requirements for most mobile medical apps because they "post minimal risk to consumers," the agency said Monday.

September 20, 2013

Perrigo Co. has hired a former Food and Drug Administration official for its regulatory department, the drug maker said.

September 19, 2013

A trade group for the generic pharmaceutical industry is hoping the Food and Drug Administration will allow biosimilars to share the same generic names as their branded biologic counterparts, saying that giving biosimilars their own generic names would not enhance safety.

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