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The FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC) has issued a warning letter to Wyeth Pharmaceuticals for misleading claims about the company’s Effexor antidepressant.
Rep. Henry Waxman (D-Calif.) has joined an international physicans’ group in alleging the Bush administration is maneuvering to protect a slice of the global market for a subset of AIDS drugs produced by brand manufacturers.
The Justice Department has told Eli Lilly that a civil investigation into the way the drugmaker markets and promotes its products is under way, Lilly announced last week.
Bristol-Myers Squibb (BMS) has filed data with the FDA from two clinical studies involving the pediatric use of its profitable cancer drug Paraplatin (carboplatin). The move was aimed at avoiding generic competition by an additional six months, the company said last week.
The FDA’s policy of relying on clinical trial data from approved drugs to OK 505(b)(2) generic drug applications is almost certain to be challenged in the courts in the future, according to a Pfizer attorney.
The FDA has approved Ketek, the first in a new class of antibiotics known as ketolides that are designed to target respiratory pathogens including those that are antibiotic-resistant, according to the drug’s manufacturer Aventis.
An International Conference on Harmonisation (ICH) draft guidance issued by the FDA can assist biological and biotechnological drugmakers in designing studies to assess whether changes in manufacturing processes adversely affect the quality, safety and efficacy of the product.
Senate Finance Committee Chairman Chuck Grassley (R-Iowa) has escalated his investigation into allegations the FDA is suppressing a report that indicates there may be an increased risk of suicide among children taking antidepressant drugs.
The FDA has released an International Conference on Harmonisation (ICH) pharmacovigilance draft guidance that outlines ways drugmakers can summarize the identified risks of a drug, the potential for unidentified risks, possible at-risk populations, and situations that have not been studied preapproval.