Recently, after reading about the severity of this year’s flu season, I finally went and got my vaccine, which my doctor had been out of when I tried in October. I received one of the last doses the clinic had on hand, and two other places I called were already out. Apparently, others in the US have been experiencing similar situations. FDA Commissioner Margaret Hamburg posted Jan. 14 on the FDA blog that vaccines are available but FDA is monitoring spot shortages. Read more »
With the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this product class. Read more »
PharmTech’s February issue will feature a guest editorial by Aaron Davidson, a partner in the life sciences practice at Baker Botts, on social media and the pharmaceutical industry. In his editorial, Mr. Davidson points to FDA and a lack of regulatory guidance as the reasons that social media has not caught on in the pharma and bio/pharma industries. FDA’s requirement to provide consumers with FDA-approved promotional materials that contain risk information may limit a pharmaceutical company’s ability to use mediums such as Twitter and Facebook effectively.
A new year has started in the world of pharmaceutical manufacturing and technology, and 2013 looks to bring plenty of innovation. PharmTech’s January issue highlights what the pharma industry can expect in the upcoming year.
Look for a discussion with FDA on the changing scope of regulatory science and its effect on drug reviews, site inspections, and approvals as well as academia’s role in the future of pharmaceutical manufacturing. We will also have a look at the future of CMOs and ISPE’s view on the future of the quality laboratory.
We would also like to know what you think the new year will bring! Please leave your comments on what your company’s goals and innovative projects are for the new year, and be sure to let us know what you would like to see us cover in the year to come!
Yesterday, FDA Commissioner Dr. Margaret Hamburg testified before the House Energy and Commerce Committee on the fungal meningitis outbreak. The purpose of the hearing was to determine why contaminated medicines entered the supply chain so that future occurrences could be prevented. Read more »
In the wake of the meningitis outbreak caused by contaminated compounded medications produced by the New England Compounding Center (NECC), both the government and the public have been wrestling with the question of how this happened—how did a company producing substandard medicines slip through regulatory oversight? Read more »
Efforts to repeal the Affordable Care Act (ACA) died on election day, as President Barack Obama won a second term in the White House and the Democrats maintained control of the Senate. House Republicans will continue to challenge various provisions in the health care legislation, but key provisions for pharmaceutical companies, such as rebates on drugs for seniors in the Part D coverage gap and authorization for biosimilars, are unlikely to change. Read more »
Last week, FDA deemed that a generic drug manufactured by Impax Laboratories and marketed by Teva Pharmaceuticals USA was not therapeutically equivalent to its reference product. The drug in question, Budeprion XL 300 mg, was approved in the US in December 2006 as a generic form of GlaxoSmithKline’s antidepressent drug, Wellbutrin XL 300 mg. Read more »
A national fungal meningitis outbreak linked to contaminated vials of steroid injectables from a Massachusetts compounding operation has reignited the debate over the safety of compounded drugs and the need for stiffer FDA regulation of these activities. Last week, the Centers for Disease Control and Prevention (CDC) reported 7 deaths and 91 ill, with the numbers rising daily. Thousands of individuals have been exposed to some 17,000 vials of methylprednisolone acetate produced by the New England Compounding Center (NECC) and shipped to 23 states in recent months. Read more »
An upcoming PharmTech Viewpoint article (Check out PharmTech’s October issue) raises that very question. Earlier this year, the New York Times reported that FDA had tracked employee emails in its investigation into the possible leak of agency information by FDA scientists who complained about the agency’s medical device review process. These scientists raised concerns about radiation danger levels.