August 20, 2014

Despite creating a detailed plan to speed up the rate at which generic drug applications are reviewed, experts say a backlog has developed at the Food and Drug Administration’s Office of Generic Drugs.

August 19, 2014

The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. 

August 14, 2014

The Food and Drug Administration has announced approval for Belsomra (suvorexant) tablets, which are used to treat insomnia.

August 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

August 4, 2014

The Council for Responsible Nutrition on Friday submitted comments to the Food and Drug Adminisration regarding the agency's proposed rule changes of nutrition and supplement facts labels. 

July 31, 2014

The Food and Drug Administration on Friday will publish the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012.

July 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

July 29, 2014

The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.

July 10, 2014

The Food and Drug Administration in late June issued a warning letter to Zarbee's for making therapeutic claims regarding a dietary supplement product.

July 3, 2014

The Food and Drug Administration on Tuesday made available a draft of its strategic priorities over the next four years for public comment.

July 2, 2014

On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.

June 20, 2014

The Food and Drug Administration has published a draft guidance document for prescription drug supply chain stakeholders as part of the agency’s implementation of the Drug Supply Chain Security Act, the National Association of Boards of Pharmacy has reported.

June 11, 2014

Strativa Pharmaceutical, a division of Par Pharmaceutical Cos., announced that the Food and Drug Administration approved Nascobal, a prescription B-12 supplement administered once a week as one spray.

June 3, 2014

Indian drug maker Wockhardt has been charged by the Food and Drug Administration with utilizing the same unapproved method to test drug quality in its Morton Grove, Ill., facility as two facilities in India, both of which were subsequently banned from importing into the United States,the Wall Street Journal reported Tuesday.

May 5, 2014

The Generic Pharmaceutical Association on Monday hired Felecia Tan for the role of AVP sciences and regulatory affairs.

March 12, 2014

Walmart has joined almost two-dozen organizations from across the healthcare supply chain in a letter calling on the Food and Drug Administration to consider the public health impact of its Proposed Rule on pharmaceutical labeling.

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.