September 10, 2014

The Food and Drug Administration recently announced the availability of the “Purple Book,” which lists biological products in much the same way that the "Orange Book" lists pharmaceuticals. 

September 9, 2014

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

August 27, 2014

The International Society for Pharmaceutical Engineering on Wednesday announced that it has released a preview of its Drug Shortages Prevention Plan aimed at helping the pharmaceutical industry avoid drug shortages and maintain a reliable supply of medications. 

August 25, 2014

Pharmaceutical company Iroko announced today that a new version its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration.

August 21, 2014

The generic drug industry — and by extension, patients across the United States — is being adversely impacted by what some are calling branded drug makers’ abuse of risk evaluation and mitigation strategies, or REMS.

August 21, 2014

Restricting access to samples of generic biological drugs would lead to nearly $140 million in lost savings for every $1 billion in biologics sales, Matrix Global Advisors said.

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 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The Food and Drug Administration will be hosting an all-day hearing on Sept. 17 seeking public comment on five draft guidance documents related to the implementation of the Generic Drug User Fee Amendments of 2012, as well as input on future policy priorities.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The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved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.