August 19, 2014

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

August 18, 2014

The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities. 

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The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved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 8, 2014

The Food and Drug Administration earlier this week announced approval for Orbactiv (oritavancin), an antibacterial drug used to treat patients with acute bacterial skin and skin structure infections.

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 29, 2014

Legislation that would speed up and streamline the Food and Drug Administration’s approval process for new sunscreen ingredients passed the House on Monday, according to published reports.

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 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

July 21, 2014

The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced.

July 16, 2014

RetireSafe, a grassroots organization advocating on behalf of America’s seniors on Tuesday released a survey finding that seniors overwhelmingly support strong patient safeguards for biosimilar medications. 

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 10, 2014

The Food and Drug Administration on Wednesday shut down a company for noncompliance of the dietary supplement current good manufacturing practice requirements. 

July 8, 2014

Attendees will have the opportunity to learn directly from the FDA about the implications of the Drug Supply Chain Security Act of 2014.

July 7, 2014

Depilatory brand Veet has announced the launch of its new Veet Infini'Silk line — the brand's first Pulsed Light FDA-cleared permanent hair reduction devices.

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 3, 2014

As the healthcare landscape continues to change at a rapid pace, the National Association of Chain Drug Stores is supporting a bipartisan initiative aimed at accelerating the pace of cures and medical breakthroughs in the United States.

July 2, 2014

The Food and Drug Administration on Tuesday issued several policy documents regarding compounding as part of the agency’s continuing effort to implement the compounding provisions of the Drug Quality and Security Act enacted in November 2013. 

July 2, 2014

As many as 32 organizations on Tuesday signed a letter calling on the Food and Drug Administration to require biologics and biosimilars to have the same International Nonproprietary Name, a practice currently in use in Europe and other markets.

June 26, 2014

The Food and Drug Administration has issued a warning that certain OTC topical acne products may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

June 25, 2014

Massachusetts Governor Deval Patrick on Tuesday enacted biosimilars legislation updating Massachusetts’s pharmacy law and paving the way for the substitution of biosimilars deemed "interchangeable" by the Food and Drug Administration.

June 25, 2014

Pharmacists in Pennsylvania may soon be required to notify physicians prior to substituing a biologic medicine with a biosimilar medication following the passing of a bill by the Pennsylvania Senate, the Associated Press reported Tuesday.

June 23, 2014

The Food and Drug Administration announced that it has approved Sivextro (tedizolid phosphate), an antibacterial drug.