Got a Form 483? Then you’ve got 15 days. Starting today, FDA will enforce its program that calls for a more timely review of its Form 483 Inspectional Observations. Under this program, a company has 15 days to respond to the observations cited in the agency’s Form 483, before the agency decides whether to issue an official warning letter. The goal of this program is to optimize FDA’s already strained resources and to move firms to promptly correct noted violations. Read more »

Last week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) released dueling statements about the proposal to establish an approval pathway for follow-on biologics that the Senate Committee on Health, Education, Labor, and Pensions (HELP) is considering. Are the two antagonists advancing the debate? Read more »

Reports of teenagers’ pharm parties, Rush Limbaugh’s OxyContin addiction, and the questions surrounding Michael Jackson’s death have kept prescription-drug abuse in the public eye. By requiring manufacturers of opioid drugs to create risk evaluation and mitigation strategies, the US Food and Drug Administration is seeking to reduce opportunities for drug abuse while keeping the therapies available to patients who need them. One pharmaceutical company suggests that, in addition to regulatory solutions, drug abuse could be curbed using drug-delivery strategies. Read more »

The US Food and Drug Administration today warned consumers to stop taking three over-the-counter versions of Zicam, made by Matrixx Initiatives (Scottsdale, AZ). The company has received a Warning Letter, but a product recall has not been issued. Read more »

The US Food and Drug Administration’s transparency task force promises to raise questions about why certain manufacturer information on drug products is kept secret. Read more »

Speakers’ comments at the Parenteral Drug Association’s Annual Meeting, held in Las Vegas on Apr. 20-24, 2009, reflected the crisis that pharmaceutical and biopharmaceutical industries face. Presenters alluded to a cloud of challenges (e.g., cost pressures, products that can be duplicated by competitors, and quality-control failures) that has been gathering for some time. Several speakers claimed that small- and large-molecule manufacturers must change now to survive in the short and long terms. But change how? Read more »

Apparently, the Bextra (valdecoxib) nightmare is lingering a bit longer for Pfizer. More than four years after the initial lawsuits against the drug were filed, a sales executive of a separate company pleaded guilty yesterday to encouraging her sales staff to promote the painkiller for uses she knew had been rejected by the US Food and Drug Administration. Read more »

The wait may soon be over for US Food and Drug Administration employees wondering who their new boss will be. President Obama is expected to introduce Governor Kathleen Sebelius of Kansas today as his new nominee for secretary of the US Department of Health and Human Services. Read more »

Now is the time when the ambitious among us decide how we’re going to improve ourselves during the new year. The pharmaceutical industry is starting 2009 with an effort to reassure the public that its interactions with doctors are on the up and up. Read more »

We’ve all seen unsuspecting movie characters laid low by poisoned drinks (as in “The Maltese Falcon”). Similar scenes were in my mind when I heard reports that trace levels of drugs had been found in American cities’ drinking water. That’s why I was happy to see that the Environmental Protection Agency (EPA) had begun to strengthen the regulation of discarded medicines. Read more »