March 3, 2014

The Food and Drug Administration last week ruled that generic equivalents to Teva Pharmaceutical's Plan B emergency contraceptive can be sold alongside Plan B without any behind-the-counter merchandising restrictions or a requirement to verify the age of the purchaser in a letter to the interested parties.

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 28, 2014

Lupin announced that it received approval from the Food and Drug Administration for rifabutin capsules USP, 150-mg, a generic version of Pharmacia and Upjohn Company's Mycobutin capsules.

February 21, 2014

Food and Drug Administration Office of Generic Drugs' acting director Kathleen Uhl highlighted the industry and FDA’s shared commitment to Generic Drug User Fee Act milestones and approaching metrics in her keynote address at the GPhA Annual Meeting taking place here.

February 21, 2014

The Food and Drug Administration will host a public meeting in March to discuss updating the OTC monograph system, the Wall Street Journal reported Friday.

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 18, 2014

To put it in Facebook terms, the pharmaceutical industry by and large has yet to friend American consumers.

February 13, 2014

Teva Pharmaceutical Industries announced that the Food and Drug Administration has granted full approval of Synribo (omacetaxine mepesuccinate) for injection.

February 11, 2014

The Generic Pharmaceutical Association announced its support of Georgia SB 370, introduced by pharmacist and Sen. Buddy Carter, R-Ga. District 1, because it will allow unimpeded patient access to interchangeable biologics.

February 11, 2014

Multicultural cosmetics brand Milani has hit the ground running this year with a new leadership team, a re-energized brand platform and marketing and communications plans to enter its next evolution in business in 2014.

February 6, 2014

The Food and Drug Administration published an interim final rule to further safeguard the health of infants fed infant formula in the United States.

January 31, 2014

The Biotechnology Industry Organization and the Indiana Health Industry Forum commended the Indiana Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

January 28, 2014

The Generic Pharmaceutical Association on Tuesday announced the hiring of Jonathan Marks as VP international affairs.

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 21, 2014

With the role of social media rapidly expanding, nearly half of pharmaceutical manufacturers are now actively using this channel to engage with patients on healthcare-related topics, according to a new report by the IMS Institute for Healthcare Informatics.

January 21, 2014

The Consumer Healthcare Products Association responded to Sen. Charles Schumer’s, D-N.Y., recent call for the Food and Drug Administration and the Consumer Product Safety Commission to require flow restrictors on all bottles of children's liquid medicines.

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

January 16, 2014

The Food and Drug Administration on Thursday issued a warning that some cryogenic wart removers — which remove warts from the skin by freezing them off — have caught fire during use at home, harming consumers or setting fire to items around the house.

January 16, 2014

The U.S. House of Representatives on Wednesday voted to restore $85 million in Food and Drug Administration sequestered user fees.

January 13, 2014

The Food and Drug Administration has found possible violations of agency regulations at a manufacturing plant in India owned by drug maker Ranbaxy Labs, the company said Monday.

January 10, 2014

The Food and Drug Administration has approved a generic drug for high blood pressure made by Actavis, the company said Friday.

January 8, 2014

The Food and Drug Administration has approved a new drug made by Bristol-Myers Squibb and AstraZeneca for treating Type 2 diabetes, the agency said.

January 8, 2014

Takeda Pharmaceutical has started a late-stage clinical trial program of its experimental drug for inflammatory bowel disease in Japan, the company said Wednesday.