We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Some staff at the FDA and the Securities and Exchange Commission (SEC) will be able to share confidential information as part of new measures for uncovering false and misleading statements by drug manufacturers, the agencies announced last week.
General disease awareness communications disseminated by drugmakers must be perceptually distinct from promotions of specific drugs or the awareness information will be subject to FDA rules governing promotional labeling and advertising, the agency said in a draft guidance last week.
The FDA would get $1.8 billion in fiscal 2005, with the lion’s share of the $149 million increase over last year’s appropriations going to food safety rather than toward programs affecting the drug industry, according to details of President Bush’s proposed budget that was released last week.
Some members of the generic drug industry are vowing to lobby for more funding for FDA’s Office of Generic Drugs (OGD) if it becomes clear the agency isn’t able to handle an increasing workload with a Bush-administration proposed fiscal 2005 budget that keeps funding levels flat.
FDA officials contend the data they have on a possible link between antidepressant use in children and an elevated risk of suicide are still too ill-defined to reach any conclusions, even though an advisory committee has recommended the agency issue stronger warnings.
Drug manufacturers could cut their costs for advertising and better educate consumers at the same time, if they follow the guidelines in one of two draft guidances on direct-to-consumer (DTC) advertising released by the FDA last week, agency officials said.
The FDA’s current pharmacogenomics draft guidance needs to include guidelines on the conditions and types of studies or study designs that would warrant DNA/RNA collection, Johnson & Johnson (J&J) told the agency recently in comments on the draft guidance.
The FDA and the Securities and Exchange Commission (SEC) have announced new measures for uncovering false and misleading statements by drug manufacturers, including establishing a blanket authorization for some staff to share confidential information
Some in the generic drug industry question the ability of the FDA’s Office of Generic Drugs (OGD) to keep up with an ever-increasing workload under President Bush’s proposed fiscal 2005 budget that keeps funding levels flat.
House Democratic leaders are demanding HHS Secretary Tommy Thompson provide to them by Feb. 17 all cost estimates associated with the new prescription drug benefit added to the Medicare program.