March 30, 2015

GNC on Monday announced an agreement with the New York Attorney General's office affirming that all of the products called into question by the office were actually in full compliance with cGMPs. 

March 27, 2015

The Food and Drug Adminisration on Friday revisited the issue of supplemental applications proposing labeling changes for approved drugs and biologic products. 

March 19, 2015

In a letter to the Senate, the Food and Drug Administration acknowledged that DNA barcoding is not routinely used to identify botanical ingredients. 

March 10, 2015

The Food and Drug Administration recently published bio-equivalence guidance documents. 

March 9, 2015

DSN examines chain pharmacy, including in-depth coverage of provider status, kiosks, Medicare and the GPhA elections, in this multi-page report.

March 6, 2015

The Food and Drug Administration approved Zarxio, making it the first approved biosimilar product in the United States.

March 5, 2015

Nutramax Labs announced Thursday the results of a National Institutes of Health-funded clinical study carried out at the Fred Hutchinson Cancer Research Center in Seattle.

 

March 2, 2015

The FDA is expected to issue new guidance on biosimilars labeling and generic opioids before the end of year, according to a report by the Regulatory Affairs Professional Society.

February 24, 2015

The Food and Drug Administration is looking into enabling holders of abbreviated new drug applications to unilaterally update their generic drug product labels prior to any branded drug change. 

February 24, 2015

NPA  renewed its call to the New York Attorney General to produce the scientific evidence behind that office's recall request of herbal supplements.

February 23, 2015

Combined Distributors reported that its medicine disposal product was found to exceed U.S. FDA and EPA guidelines. 

February 17, 2015

The Food and Drug Administration last week issued five draft documents related to drug compounding and repackaging that will help entities comply with important public health provisions.

February 6, 2015

The pharma industry praised outgoing Food and Drug Administration commissioner Margaret Hamburg and welcomed Stephen Ostroff, who will assume the role of acting commissioner.

February 5, 2015

Food and Drug Commissioner Margaret Hamburg will resign from her post in March.

 

February 4, 2015

DSN examines chain pharmacy, including in-depth coverage of telehealth, generic drug prices, and the GPhA CEO to step down, as well as Uhl appointed director of OGD, in this multi-page report.

January 28, 2015

The House Energy and Commerce Committee on Tuesday released a discussion document in the 21st Century Cures initiative.

January 27, 2015

Rep. Jason Chaffetz, R-Utah, last week introduced a bill that would extend to new combination drugs containing molecules already approved by the Food and Drug Administration the same five-year market exclusivity as a drug product containing an entirely new set of active ingredients.

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.