December 16, 2014

Apira Science announced on Tuesday that the FDA has granted the company OTC clearance for its iGrow Hair Growth System to promote hair growth in women with Fitzpatrick skin phototypes I to IV, and with Ludwig Baldness Scale Classifications of I to II.

December 12, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at FDA reform and its potential impact on healthcare costs, in this multi-page report.

December 12, 2014

Sanofi Pasteur announced that the FDA approved the supplemental biologics license application for Fluzone Intradermal Quadrivalent vaccine.

December 11, 2014

The Food and Drug Administration on Wednesday approved Gardasil 9 for the prevention of certain diseases caused by nine types of human papillomavirus.

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The FDA issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product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The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by the industry on Jan. 1, 2015. 

November 19, 2014

The Food and Drug Administration opened a public docket and requested comments on proposed criteria for “first generic” abbreviated new drug application submissions.

 

November 18, 2014

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a look at the impact of the Hatch-Waxman act and Q&A's with industry leaders, in this multi-page report.

November 17, 2014

Genzyme, a Sanofi company, on Friday announced that the Food and Drug Administration approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis. 

November 17, 2014

SpermCheck in August gained additional retail distribution for its SpermCheck Fertility, an FDA-approved at-home screening test that determines with 98% accuracy whether a man has a normal or low sperm count. Infertility affects nearly 7 million U.S. couples every year. 

November 14, 2014

The Council for Responsible Nutrition has launched a tool that compiles Food and Drug Administration warning letters sent to dietary supplement companies into a searchable database.

November 13, 2014

CVS/pharmacy has introduced a new CVS/pharmacy Brand Advanced Glucose Meter, a Food and Drug Administration-approved meter for at-home glucose monitoring.

October 22, 2014

The Food and Drug Administration last week announced plans to survey pharmacists and patients about their experiences resulting from changes in generic drug pill appearance.

October 22, 2014

A JAMA study noted that about two-thirds of dietary supplements recalled by the Food and Drug Administration still contained banned ingredients at least six months after being recalled.

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 10, 2014

The Food and Drug Administration on Friday approved Gilead's Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus genotype 1 infection.

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.

October 9, 2014

The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products. 

October 7, 2014

The Network for Excellence in Health Innovation on Monday announced the recipients of its 2014 Innovators in Health award, which recognizes individuals whose work reflects the spirit of NEHI and embraces the mission of improving the quality of health care and reducing costs for patients and their families. 

October 6, 2014

Healthcare Distribution Management Association released a statement in support of the FDA’s “Know Your Source” campaign.

October 3, 2014

SpermCheck on Thursday launced SpermCheck Fertility, an FDA-approved at-home screening test that determines with 98% accuracy whether a man has a normal or low sperm count.

September 18, 2014

The Generic Pharmaceutical Association on Thursday provided input on the Generic Drug User Fee Act process before the Food and Drug Administration.