December 8, 2014

President Barack Obama signed into law in late November the Sunscreen Innovation Act.

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The FDA issued a draft guidance that would provide generic companies a pathway to obtain samples of medicines requiring a Risk Evaluation and Mitigation Strategy (REMS) protocol for product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 5, 2014

NACDS' VP business development Roy McGrath was one of 31 new members named to Maryland Governor-elect Larry Hogan's transition team.

December 4, 2014

Mylan on Thursday announced that its subsidiary, Mylan Labs, was granted tentative approval from the Food and Drug Administration for two dosages of abacavir/lamivudine tablets for oral suspension. 

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 2, 2014

Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration on its abbreviated new drug application for diclofenac sodium topical solution 1.5% w/w.

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The Food and Drug Administration recently issued draft guidance on key product tracing provisions of the Drug Supply Chain Security Act, which is expected to be implemented by the industry on Jan. 1, 2015. 

December 1, 2014

GlaxoSmithKline last week announced that the Federal Trade Commission has approved GSK's acquisition of Novartis' vaccines business and the creation of a joint consumer care company between GSK and Novartis.

 

November 21, 2014

According to reports, House Republicans filed a lawsuit Friday charging the Obama administration with overreaching in the implementation of the Affordable Care Act. 

November 20, 2014

The Consumer Healthcare Products Association board of directors on Wednesday announced changes to CHPA’s voluntary guidelines addressing dosing of liquid pediatric over-the-counter medicines.

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 17, 2014

Thirty years ago, Democratic and Republican members of Congress hammered out a rare and prescient bipartisan compromise bill that transformed the pharmaceutical landscape forever and unleashed the modern generic drug industry. That law, known as the Hatch-Waxman Act, has proven to be one of the most far-reaching and impactful pieces of legislation ever to shape the American healthcare system.

November 17, 2014

Solgar on Friday voluntarily recalled its ABC Dophilus Powder.

November 14, 2014

Almost 23% of high school students currently use a tobacco product, according to new data published by the Centers for Disease Control and Prevention.

 

November 14, 2014

Each year Americans make nearly a million doctor visits for eye infections, resulting in $175 million in direct healthcare costs, the Centers for Disease Control and Prevention estimated.

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

 Janssen Pharmaceuticals announced that the Food and Drug Administration approved the company's supplemental new drug application for the once-monthly Invega Sustenna (paliperidone palmitate), an antipsychotic used to treat schizoaffective disorder as either monotherapy or adjunctive therapy. 

November 11, 2014

Dr. Reddy's Labs received approval from the Food and Drug Administration for a generic version of Roche Holding's antiviral medication Valcyte, according to a Reuters report

November 7, 2014

The Consumer Healthcare Products Association urged the president to support changing the mandate that consumers obtain a prescription in order to utilize FSAs and HSAs to purchase over-the-counter medicines.

November 7, 2014

Janssen Therapeutics announced earlier this week that the Food and Drug Administration approved Olysio (simeprevir), a hepatitis C virus NS3/4A protease inhibitor, in combination with sofosbuvir as an all-oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C (CHC) infection in adult patients as part of a combination antiviral treatment regimen. 

November 6, 2014

The NACDS-PAC supported a majority of winners in Tuesday's elections, comprising 86% in Senate races and 93% in House races, Steven Anderson, president and CEO of the National Association of Chain Drug Stores, said in a memo released Wednesday.

November 6, 2014

Although the GOP controls both houses, it is unlikely that they will be able to repeal Obamacare, according to an article in the Wall Street Journal published Wednesday.

November 4, 2014

The Iowa Board of Pharmacy is revisiting advocating the medical use of marijuana to state legislators.

November 3, 2014

Protein Sciences Corp. last week announced that the Food and Drug Administration approved Flublok influenza vaccine for all adults ages 18 years and older.