Content about Therapeutics

March 10, 2014

A Maryland bill that is intended to help pharmacies in managing inventories and avoid potential drug shortages could create hardships for distributors, according to an FDA law blog.

March 6, 2014

In anticipation of the March 13 deadline for comments on the FDA's proposed rule on prescription generic drug labeling, 21 health industry groups submitted a new letter to the agency on Thursday, raising concerns about the proposed regulation.

March 6, 2014

The administration is seeking $4.7 billion for the Food and Drug Administration, representing a 6.8% increase, according to a report published Tuesday by the Washington Post.

March 3, 2014

The Generic Pharmaceutical Association on Friday hosted a Congressional briefing highlighting the economic impact the Food and Drug Administration’s proposed rule on prescription labeling that would allow for label changes without prior FDA approval.

February 19, 2014

The Food and Drug Administration announced the initiation of the Secure Supply Chain Pilot Program to enhance the security of imported drugs.

February 18, 2014

In a blog post updated Friday, Food and Drug Administration commissioner Margaret Hamburg addressed two challenges facing Indian drug manufacturers — approval times for abbreviated new drug applications and quality inspections.

February 3, 2014

The Food and Drug Administration is investigating the risk of stroke, heart attack and death in men taking FDA-approved testosterone products, the agency announced Friday.

January 22, 2014

The Food and Drug Administration launched the advisory committee membership nomination portal, an online, interactive system that allows interested individuals to submit nominations for membership to any of the agency’s 33 advisory committees.

January 2, 2014

The number of new drugs approved by the Food and Drug Administration fell by more than 30% in 2013 compared with 2012, according to agency records.

December 9, 2013

The Food and Drug Administration's Office of Generic Drugs will be elevated to a "super office," a top official in the agency told staff members in a memo Monday.

November 20, 2013

Following actions by the Food and Drug Administration, USPLabs has agreed to recall and destroy the dietary supplement OxyElite Pro, as it has been linked to dozens of cases of acute liver failure and hepatitis, including one death and illnesses so severe that several patients required liver transplants, the agency noted Wednesday.

November 15, 2013

A Food and Drug Administration expert panel has voted to recommend approval for a drug to treat a circadian rhythm disorder that affects most people with total blindness.

November 14, 2013

The Food and Drug Administration has requested label and packaging changes of certain over-the-counter topical antiseptic products, according to an FDA MedWatch alert.

November 8, 2013

When the maker of a branded drug updates the safety information on its product labeling, makers of generic versions of that drug must wait until the Food and Drug Administration approves the new labeling before they can update theirs, but that could soon change under a rule proposed by the FDA.

October 25, 2013

A Food and Drug Administration expert panel has recommended approval for a drug made by Johnson & Johnson for treating hepatitis C, the company said.

October 22, 2013

The Food and Drug Administration has approved drugs for depression and smoking cessation made by Jubilant Life Sciences, the company said.

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

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.

September 10, 2013

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

August 22, 2013

The Food and Drug Administration has approved a supplemental regulatory application from Mylan for a generic antidepressant that was subject last year to scrutiny by the agency amid reports of efficacy problems, Mylan said Thursday.

July 23, 2013

The Food and Drug Administration on Tuesday took action to remove from the market illegal products, including some labeled as dietary supplements, that claim to mitigate, treat, cure or prevent diabetes and related complications.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

June 5, 2013

South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug.

April 29, 2013

A Food and Drug Administration staffer who has led implementation of the Generic Drug User Fee Act has been named to a new director position at the agency, the FDA said Monday.

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