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Prioritizing applications for off-patent drugs is one way to eradicate the backlog of generic drug applications at the Office of Generic Drugs (OGD), according to a top FDA official.
The Generic Pharmaceutical Association (GPhA) recently took the Congressional Budget Office (CBO) to task for its recent letter to Sen. Charles Schumer (D-N.Y.), in which CBO downplayed potential consequences of raising the drug rebates paid by generic drug manufacturers to the Medicaid program.
The FTC plans to investigate the competitive effects that authorized generics are having on the drug industry, yet another sign that the agency is taking a harder line against potentially anticompetitive deals between drugmakers.
The FDA’s Office of Generic Drugs (OGD) has launched its Dissolution Methods Database aimed at improving the quality and turnaround time of abbreviated new drug applications (ANDAs).
Generic drugmakers will have a harder time litigating patent suits if a proposed patent reform bill is approved, but not all the changes would have a significant negative effect on the generic industry, according to patent lawyers.
The FDA can and should create an approval process for follow-on biologics, said pharmaceutical industry experts at the recent Generic Pharmaceutical Association (GPhA) conference, but an agency official countered that there is still a lot to learn about the complexity and risks of such drugs.
The FDA’s chief counsel wants to reform the citizen petition process to discourage brand drugmakers from filing petitions simply to delay generic drug debuts.
Eight out of 10 Americans want to have the option to choose authorized generic drugs, according to a study commissioned by Prasco Laboratories, an Ohio-based drugmaker focused on marketing authorized generics.
Eight out of 10 Americans want to have the option to choose authorized generic drugs, according to a study commissioned by Prasco Laboratories, an Ohio-based drugmaker focused on marketing authorized generics.
Generic drug industry representatives are continuing their assault on several provisions in recently proposed biodefense legislation, including a definition of “countermeasure” that could include virtually all marketed drugs.