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Dental bone repair materials may be reclassified from Class III to Class II devices if a proposal the FDA recently released is finalized.
The agency proposed a reclassification of tricalcium phosphate (TCP) granules for dental bone repair and all other bone grafting materials for dental indications into Class II (special controls), according to a Federal Register notice posted on June 30.
The FDA’s Dental Products Advisory Panel voted July 13 to recommend conditional approval of a combination product intended to treat osseous defects caused by periodontal disease.
The FDA's highly anticipated third-party inspection program is taking longer to get off the ground than expected, largely due to a lack of funding to train the inspectors who will participate in the program, industry sources report.
Concerns about the clinical efficacy of chronic angina treatment transmyocardial revascularization (TMR) with coronary artery bypass graft (CABG) led the Medicare Coverage Advisory Committee (MCAC) to a vote of moderate confidence on the procedure at a July 14 meeting.
Three popular Rx drugs purchased from a website advertised as Canadian revealed the products to be potentially dangerous, according to the FDA, which analysized the purported generic versions of the drugs.
The FDA is on track to approve more new molecular entities (NMEs) this year than it did last year. For the first six months of 2004, the FDA approved 12 NMEs, compared to only seven for the comparable period in 2003 and 17 NMEs for all of 2002.
Generic firm Mylan Laboratories will likely sue the FDA over the agency’s refusal to prohibit the marketing and distribution of authorized generics until after the first generic firm’s 180-day exclusivity period has expired.
By voice vote, the House has approved a measure to penalize the FDA’s Office of Chief Counsel for defending drug manufacturers in lawsuits brought by families of patients who died using the companies’ products, and for attempting to deceive Congress about ties the agency’s chief counsel had to the industry.
A joint FDA advisory committee said it could not approve Allergan’s oral retinoid treatment for psoriasis because even though the treatment demonstrated modest efficacy in pivotal trials, the accompanying risk management program is inadequate.
A District of Columbia federal court has refused King Pharmaceuticals’ request to revoke FDA approval of supplemental new drug applications (sNDAs) that propose to establish bioequivalence between King’s thyroid product Levoxyl and two other products: Jerome Stevens’ Unithroid and Mova Pharmaceutical’s Levo-T.