January 16, 2015

Kathleen "Cook" Uhl on Thursday was named director of the Food and Drug Administration's Office of Generic Drugs.

 

January 14, 2015

The Food and Drug Administration established the Office of Pharmaceutical Quality, a new division tasked with improving quality control at pharmaceutical manufacturing facilities.

 

January 8, 2015

Sandoz may be on track to receive the first biosimilar drug approval from the Food and Drug Administration for its Zarxio.

January 7, 2015

With tens and possibly hundreds of billions of dollars in potential savings still snagged in a regulatory limbo, federal lawmakers and health industry stakeholders strongly urged the Food and Drug Administration last month to knock down the final barriers to review and approval of biosimilar drugs for marketing in the United States.

January 7, 2015

The pharmaceutical industry is back. Fueled by the launch of expensive, new biotech medicines, rising prices for both branded and generic drugs and a recent slowdown in branded-drug patent expirations and generic competition, the U.S. pharmaceutical market is staging a remarkable resurgence.

January 5, 2015

DSN examines chain pharmacy, including in-depth coverage of pharmacy technology, biosimilars and generics, as well as a Q&A with Owen Mumford's Travis Shaw, in this multi-page report.

December 29, 2014

In a staff memo, the Office of Generics Drug’s acting director, Kathleen Uhl, vowed to take action on 90% of the abbreviated new drug application backlog before October 2017, and has appointed Ted Sherwood as acting director of OGD’s Office of Regulatory Operations to help with the improvements, FDANews.com has reported.

December 23, 2014

Teva Pharmaceutical today announced that the Food and Drug Administration has approved Granix (tbo-filgrastim) Injection for self-administration by patients and caregivers. With the approval of this additional administration option, physicians will soon have the flexibility to prescribe Granix for either in-office or at home use.

December 22, 2014

The Food and Drug Administration has approved Zerbaxa (ceftolozane/tazobactam), a new antibacterial drug product, to treat adults with complicated intra-abdominal infections and complicated urinary tract infections.

December 17, 2014

To date, the Food and Drug Administration's Center for Drug Evaluation and Research has approved 35 novel new drugs in 2014, compared to 27 in 2013. 

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 11, 2014

After a recent spike in the prices charged for some generic drugs led to outcries from pharmacists, patient advocates and federal lawmakers, a report issued last month suggests that drug costs can be controlled if the Food and Drug Administration changes the way it handles reviews and approvals.

 
December 9, 2014

The Generic Pharmaceutical Association agreed to support compromise automatic substitution legislation.

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.

November 20, 2014

The Generic Pharmaceutical Association on Thursday emphasized the savings generic medicines bring to the table in light of rising brand prices. 

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

DSN spoke with Neas in late October to mark the 30th anniversary of the landmark Drug Price Competition and Patent Term Restoration Act — better known as the Hatch-Waxman Act. 

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 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 7, 2014

Teva Pharmaceutical on Friday announced positive findings from a Phase III clinical study that examined the safety and efficacy of Qnasl.

November 3, 2014

The RAND Corp. projected that the introduction of biosimilar drugs in the United States will reduce direct spending on biologics by $44.2 billion from 2014 to 2024.