February 26, 2015

Congress introdues legislation to protect FDA user fees from sequestration. 

February 26, 2015

The fixed-combination drug Avycaz was granted priority review by the Food and Drug Administration. 

February 23, 2015

Combined Distributors reported that its medicine disposal product was found to exceed U.S. FDA and EPA guidelines. 

February 6, 2015

The pharma industry praised outgoing Food and Drug Administration commissioner Margaret Hamburg and welcomed Stephen Ostroff, who will assume the role of acting commissioner.

February 5, 2015

Food and Drug Commissioner Margaret Hamburg will resign from her post in March.

 

January 27, 2015

Rep. Jason Chaffetz, R-Utah, last week introduced a bill that would extend to new combination drugs containing molecules already approved by the Food and Drug Administration the same five-year market exclusivity as a drug product containing an entirely new set of active ingredients.

January 14, 2015

The Food and Drug Administration established the Office of Pharmaceutical Quality, a new division tasked with improving quality control at pharmaceutical manufacturing facilities.

 

December 22, 2014

The Food and Drug Administration has approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.

December 5, 2014

The FDA issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product testing.

December 3, 2014

The Food and Drug Administration published a final rule that sets standards for how information about using medicines during pregnancy and breastfeeding is presented in the labeling of prescription drugs and biological products.

 

December 1, 2014

The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by the industry on Jan. 1, 2015. 

October 14, 2014

Twenty African-American and Hispanic community and health care organizations earlier this month submitted a letter to the Food and Drug Administration raising concerns that its Proposed Rule on Generic Labeling could jeopardize patient safety and access to affordable medicines. 

October 9, 2014

Congress and the sports nutrition industry independently called upon the Food and Drug Administration to act on removing an untested synthetic stimulant that was found in 12 products marketed as sports nutrition supplements.

September 15, 2014

Mylan announced that its subsidiary, Mylan Labs Limited, has signed an agreement with Gilead Science under which Mylan has been licensed the non-exclusive rights to manufacture and distribute sofosbuvir and the investigational single-tablet regimen of ledipasvir/sofosbuvir in 91 developing countries. 

September 9, 2014

The Food and Drug Administration is on pace to match or exceed the 39 novel new medicines approved in 2012.

September 8, 2014

Mylan is now free to resume distribution of its generic Precedex product (dexmedetomidine hydrochloride injection) to customers, effective immediately. 

August 21, 2014

The Food and Drug Administration cleared South Korean company Philosys’ Gmate blood-sugar monitoring device for U.S. marketing on Aug. 15.

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.