April 21, 2015

A new PhRMA report released Monday found that branded manufacturers invested $51.2 billion last year in R&D. 

April 21, 2015

The National Minority Quality Forum on Tuesday honored PhRMA's John Castellani, for helping to increase diversity in clinical trials. 

April 20, 2015

DSN examines chain pharmacy — including in-depth coverage of provider status, generics, pharmacy deserts, point-of-care testing and more — in this multi-page report.

April 17, 2015

Generic Pharmaceutical Association branches out with the creation of the Biosimilars Council. 

April 16, 2015

According to the Food and Drug Administration, heart failure is a common condition that affects close to 5.1 million people in the United States. The condition arises when the heart cannot pump enough blood to meet the body’s needs. 

April 13, 2015

Supplement industry under continued fire with latest criticism of FDA oversight of BMPEA ingredient coming from Sen. Chuck Schumer, D-N.Y.

April 2, 2015

Alere's i Strep A test received marketing clearance from the Food and Drug Administration on Thursday. 

March 31, 2015

The director of the FDA’s Office of Generic Drugs temporarily steps down to deal with a medical issue, according to a report by the Regulatory Focus Professionals Society.

March 30, 2015

The supplement industry criticized the agreement between GNC and the New York Attorney General's office. 

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.