Section 505(b)(2) was added to the Act by the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch-Waxman Amendments). This provision expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant. Sections 505(b)(2) and (j) together replaced FDA's paper NDA policy, which had permitted an applicant to rely on studies published in the scientific literature to demonstrate the safety and effectiveness of duplicates of certain post-1962 pioneer drug products (see 46 FR 27396, May 19, 1981). Enactment of the generic drug approval provision of the Hatch-Waxman Amendments ended the need for approvals of duplicate drugs through the paper NDA process by permitting approval under 505(j) of duplicates of approved drugs (listed drugs) on the basis of chemistry and bioequivalence data, without the need for evidence from literature of effectiveness and safety. Section 505(b)(2) permits approval of applications other than those for duplicate products and permits reliance for such approvals on literature or on an Agency finding of safety and/or effectiveness for an approved drug product.
the problem is evidently that they dont know how to file an application so that it can be approved, 4 and 5 yrs have passed and other companies are getting approvals and we hear nada. This appears to be a smoke screen to me at this point. I agree with teberb on his challenge show me the proof, I am from Missouri.
Before drugs like Lipitor or Zoloft could begin to realize their earning potential, they had to be approved by the FDA under the standard 505(b)(1) regulatory pathway. Historically, drugs under 505(b)(1) take as long as 15 years and a nine-figure investment to work their way through the system.
Drugs approved under 505(b)(2), on the other hand, can rely in part on data from existing reference drugs. This means they can be developed and achieve FDA approval in as little as 30 months with only a fraction of the number of required clinical trials and at much lower cost. Additionally, unlike generic drugs approved under Section 505(j), where exclusivity can be held for only 180 days, the 505(b)(2) applicant may qualify for three, five, or seven years of market exclusivity, depending on the extent of the change to the previously approved drug and the type of clinical data included in the New Drug Application (NDA). Less