May 19, 2016

Stat is reporting that the Food and Drug Administration has delayed its issuing of a final rule that would let drug manufacturers update the safety warnings on their products independently, rather than seeking FDA approval to do so. The report notes that this is the second time the FDA final rule issuance has been delayed since the rule was proposed in 2013. The proposed rule has been met with opposition from such organizations as CVS and various groups representing manufacturers, pharmacists and wholesalers due to the number of different labels that would come out of the rule. (Stat)

May 18, 2016

The ad notes that more than 60% of the U.S. House of Representatives and more than 40% of the U.S. Senate have cosponsored legislation to name pharmacists as healthcare providers in Medicare Part B.

May 16, 2016

Last month, President Barack Obama signed into law the Ensuring Patient Access and Effective Drug Enforcement Act of 2016 that was advocated by the National Association of Chain Drug Stores and other industry groups. 

May 13, 2016

In the 2015 State of the Union address, President Barack Obama announced the launch of the Precision Medicine Initiative — a bold new research effort that can be actuated by MD Labs' Rxight, a pharmacogenetic program. 

May 13, 2016
CHPA's RSQ conference this year will focus on "Collaborating for Consumer Healthcare Solutions," showing how collaboration between industry and regulators can drive better consumer health outcomes.
 
May 12, 2016

The Council for Responsible Nutrition on Wednesday initially stood up against this proposed pre-market approval requirement on dietary supplements being sold on U.S. military bases.

May 11, 2016

CRN noted that the additional rule would be duplicative of regulations already on the books.

May 11, 2016

A nonprescription drug user fee program would provide funding to supplement congressional non user-fee appropriations, and would support timely and efficient FDA review of ingredients in a monograph, agency says.

May 11, 2016

An Inc. story published Tuesday covered the story of how a small, entrepreneurial company took on the Food and Drug Administration, and won. In a ruling reversal, FDA has allowed KIND to once again promote its bars as "healthy." For Daniel Lubetzky, the founder and chief executive of KIND, the FDA's response showed the power a small business can have when it takes a stand against a large government agency. "What makes us entrepreneurs is that we are stubborn and don't take no for an answer," Lubetzky told Inc. "And when we believe in something, we don't stop until we achieve what's right." (Inc.

May 10, 2016

The FDA reversal follows a warning letter issued by the agency in March 2015, requesting removal of the word healthy from the back panel of four KIND wrappers and its web site.

May 3, 2016

The news comes as the National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB) seeks to reduce the number of antibiotic prescriptions by 15% by 2020.

May 3, 2016

Patient advocate and community pharmacy champion Rep. Cathy McMorris Rodgers, R-Wash., will serve as the featured speaker at this year's opening lunch on May 24.

May 2, 2016

According to Veterans Affairs estimates, the price range for IUD costs to the military is $350 to $650 per device. Allergan will offer its IUD to the military treatment facilities and VA hospitals for $55.83.

April 29, 2016

Georgia is the last state in the southeast to adopt NPLEx, as all of its neighboring states – South Carolina, Florida, Alabama, Tennessee and North Carolina – adopted the system in previous years.

April 28, 2016

CMS' final rule includes an NACDS-backed provision to strengthen patient access to care.

April 26, 2016

By combining all of the necessary blood glucose testing supplies into a convenient, self-contained 10-test cartridge, POGO provides ease of use and discretion for millions of patients.

April 20, 2016

According to the most recent data from the FDA’s Population Assessment of Tobacco and Health study, 31.8% of rural, white males 12-17 years of age are either experimenting with, or at-risk for, using smokeless tobacco.

April 20, 2016
“Women, infants and children utilizing the WIC program deserve equal access to and should be allowed to purchase vitamins,” stated Dan Fabricant, CEO and executive director of NPA. 
April 20, 2016

The Ensuring Patient Access and Effective Drug Enforcement Act of 2016 seeks to increase collaboration between health and enforcement bodies on drug abuse solutions.

April 20, 2016

Since being hired by the UFC in 2015, Jeff Novitzky has crafted and implemented the strictest drug-testing program in professional sports conducted by the U.S. Anti-Doping Agency.

April 15, 2016

A new bill looks to push the FDA into rewriting a guidance on generic drug and biosimilar naming by withholding funding unless it meets Congress’ requests. 

April 14, 2016

DSN examines chain pharmacy, including in-depth coverage of specialty pharmacy, orphan drugs and biosimilars, in this multi-page report.

 

April 14, 2016

In 2015, the OGD granted 580 approvals and 146 tentative approvals, including 99 in December alone – the largest number of drug approvals given out in a single month. 

April 13, 2016

Biologic medications — nine of which were among the Food and Drug Administration’s approvals in 2015 — constitute a big portion of the specialty market.