March 19, 2013

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

March 19, 2013

The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

March 19, 2013

The question of whether a generic drug company can be held liable for harmful side effects from its medicines goes before the Supreme Court Tuesday in a case involving a New Hampshire woman who sustained several injuries after taking a generic pain drug.

March 18, 2013

The Food and Drug Administration has approved a generic treatment for bronchospasm made by Mylan, the drug maker said Monday.

March 14, 2013

The Food and Drug Administration has approved a drug for obsessive compulsive disorder made by Par Pharmaceutical Cos., the drug maker said Thursday.

March 14, 2013

The Food and Drug Administration will decide in late August whether to approve an experimental opioid painkiller made by QRxPharma, the drug maker said Thursday.

March 14, 2013

The director of the Food and Drug Administration's Office of Generic Drugs is stepping down, according to published reports.

March 14, 2013

SoloHealth on Thursday announced it has been selected as one of the Technology Association of Georgia’s Top 10 Innovative Technology Companies. SoloHealth was recognized for its FDA-approved health and wellness kiosk, the SoloHealth Station.

March 12, 2013

The attorneys general of 46 states and two territories are calling on the Food and Drug Administration to make prescription painkillers harder to abuse.

March 11, 2013

Nearly 1,000 biotech drugs and vaccines for more than 100 diseases are currently under development, according to a new report.

March 8, 2013

While the Food and Drug Administration released draft guidance on regulations for biosimilars in February 2012, the final regulations have yet to appear. But already, everyone from analysts to trade groups to drug makers is preparing for a time when knock-off versions of biotech drugs will become available.

March 5, 2013

Generic drug maker Dr. Reddy's Labs has launched a drug used to treat certain cancers, the company said Tuesday.

March 5, 2013

The stakes are high in a case involving generic drug maker Actavis and the Federal Trade Commission that will soon go before the Supreme Court, the head of a generic drug industry lobbying group said in a conference call with reporters Tuesday.

March 4, 2013

The Food and Drug Administration has accepted a regulatory application for a new painkiller from Iroko Pharmaceuticals, the drug maker said.

March 4, 2013

The Food and Drug Administration will inspect about 30 compounding pharmacies that it has deemed "high risk," according to published reports.

March 1, 2013

The Supreme Court will hear arguments later this month in a case that could determine the future of many patent settlements between brand and generic drug makers.

February 28, 2013

Biosimilar medicines have been approved and routinely prescribed in Europe for nearly seven years, and creation of a clear pathway for Food and Drug Administration review and approval of generic versions of bioengineered drugs was enshrined into law in the United States with the passage of the Patient Protection and Affordable Care Act nearly three years ago.

February 26, 2013

The Food and Drug Administration has approved a drug for postmenopausal women who experience pain during sex.

February 26, 2013

Drug maker Ranbaxy Labs has started producing the ingredients for a cholesterol drug while working with the Food and Drug Administration to fix manufacturing issues that led to the recall in November 2012 of several batches of the drug.

February 25, 2013

The Food and Drug Administration has approved a new drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the digestive system, the agency said Monday.

February 22, 2013

The Food and Drug Administration has approved a new treatment for late-stage breast cancer, the agency said.

February 22, 2013

One of the FDA's chief duties is ensuring the quality of food and drug products, and that was the focus of a keynote address delivered at the GPhA annual meeting.

February 21, 2013

The Food and Drug Administration has approved a new vial size for a drug made by CSL Behring to treat a bleeding disorder and an immune disorder, the company said.

February 19, 2013

The Food and Drug Administration has approved a generic diabetes drug made by Aurobindo Pharma, the drug maker said.