Advertising of Prescription Drugs – Keeping it Honest and Balanced

It is well known that the pharmaceutical industry spends billions each year on promoting their products, especially to healthcare professionals. In the US, a significant amount is also spent on direct advertising to consumers. In a report by the FDA on Keeping Drug Advertising Honest and Balanced, Thomas Abrams, director of the Office of Prescription Drug Promotion (OPDP), shares on how the agency “protects consumers from false and misleading ads for prescription drugs that appear on TV, radio, online and in print publications.” Read more »

Quality Manufacturing Key to Global Attack on Fake Drugs

Jill Wechsler Washington EditorThe growing dangers from substandard and falsified medicines around the world has prompted a blue-ribbon panel formed by the Institute of Medicine (IOM) to call for clear international standards for higher quality medical products,  plus an electronic tracking system in the US to uncover bogus products in the supply chain. Read more »

Future Hub of Biotech: Boston or San Francisco?

San Francisco and Boston sit on opposite coasts and each has a rich history and character that make them distinct. However, they share some similarities: both cities are centers of top biotechnology hubs in the US. Read more »

Spot Shortages and New Approvals for US Influenza Vaccine

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 »

FDA’s Position on Abuse-Deterrant Opioid Formulations Becomes Clearer

Amy RitterWith the release of a draft guidance on the evaluation and labeling of abuse-deterrent opioid formulations, FDA is one step closer to clarifying its thinking on acceptable formulations for this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 »

Social Media and the Pharma Industry

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.

Read more »

A New Year in Pharma

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!

A Tough Time for FDA at House Hearings

Amy RitterYesterday, 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 »

Will FDA Gain More Oversight Over Compounders?

Amy RitterIn 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 »

Key Healthcare Challenges for Obama, Congress

Jill Wechsler Washington EditorEfforts 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 »

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