October 15, 2013

The Food and Drug Administration has approved a new generic drug from Teva Pharmaceutical Industries for treating eye infections, the company said.

October 14, 2013

The governor of California has vetoed a bill that critics said would have limited patients' access to knock-off versions of biotech drugs.

October 11, 2013

A new law in Maine will allow the importation of drugs from abroad through mail-order from some pharmacies, formalizing a practice that has existed in many parts of the country for several years, and marking the first time a state government has, by law, gone against Food and Drug Administration regulations that bar importation of drugs.

Bloomberg columnist Megan McArdle said Maine was "going rogue" on drug importation, and that pretty much sums it up. The state, which has long had a close relationship with Canada — its governor, Paul LePage, is of French-Canadian descent and spoke Quebecois French as his first language — is openly defying federal law. And because federal law ultimately trumps state law, it's likely the federal government will crack down at some point.

October 10, 2013

When it comes to laws and regulations, what happens in Europe stays in Europe generally, and doesn’t have much bearing on the United States. But a recent win in Europe for U.S. drug maker Hospira could have some implications for the United States as well.

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 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 7, 2013

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

October 4, 2013

A new mobile game app designed by CyberDoctor showed improvements in medication adherence, diet and exercise in diabetes patients, according to a study.

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

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

September 19, 2013

Inovalon and Walgreens on Thursday announced that they have entered into a multi-year agreement to provide Inovalon's data-driven encounter support platform, Electronic Patient Assessment Solution Suite (ePASS) within Healthcare Clinic at select Walgreens to support improvements in managed care quality and performance.

September 17, 2013

The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

September 16, 2013

The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 13, 2013

Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.