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The article discusses the approval of U.S. Food and Drug Administration (FDA) on the new drugs which predicts clinical benefits. Topics mention including the drug manufacturers who commits on conducting a postapproval trials which confirms the efficacy of drugs, revision of drug labelling and several drugs which are selected and have received the accelerated approval since 2011 with their cost.

The authors reflect on the regulation of off-label promotion of drugs, highlighting the case of pharmaceutical sales representative Alfred Caronia, who promoted sodium oxybate for off-label use. Topics include the clinical trials required by the Food and Drug Administration (FDA) to demonstrate the safety and efficacy of the drugs, the misbranding of non FDA-approved drugs and the guidelines released by the drug and biologics industry for off-label promotion.

The author expresses his concerns about a program implemented by the U.S. Food and Drug Administration (FDA) Amendments Act of 2007 which promotes the development of pharmaceutical products for neglected diseases. Sponsors of a drug for a tropical disease are given vouchers for expedited FDA review of a drug application. The author believes the program is inefficient. He also believes that FDA review which is too speedy may lead to bad regulatory decisions. Alternative approaches are discussed.

The article discusses the breakthrough therapy designation created by U.S. Congress to expedite Food and Drug Administration testing as well as approval of drugs aimed at treating serious diseases. Manufacturers were allowed to employ many programs to combine different advantages which reduced cost of drug development.

The article focuses on several aspects of the Prescription Drug User Fee Act (PDUFA) in the U.S. It mentions that U.S. President Donald Trump signed into law the sixth version of key legislation for the U.S. Food and Drug Administration (FDA), known as the Prescription Drug User Fee Act (PDUFA VI) on August 2017. It also mentions that nonsteroidal antiinflammatory drug rofecoxib (Vioxx) was removed from market when it was found to substantially increase the risk of cardiovascular events.

The article discusses the access to injectable generic drugs, with focus on bacille Calmette-Guérin for bladder cancer. It notes the prospect of a sustained shortage or substantial price increase after a BCG manufacturer announces in November 2016 to exit the market in mid-2017. It illustrates the price increase of mitomycin, thiotepa, and valrubicin during the BCG shortage beginning in 2014. Also noted is payment reforms which could further stabilize the generic injectable agents market.

The authors discuss the challenges and developments regarding follow-on biologics. The authors agree about the major advances of biologics in treating rheumatologic diseases and cancers while forecasts on their use and costs are expected to rise sharply. Also discussed are approval of the U.S. Food and Drug Administration (FDA) for filgrastim-sndz (Zarxio) from Sandoz, the 1984 Hatch-Waxman Act and other follow-on biologics including versions of epoetin alfa, infliximab and pegfilgrastim.

The article focuses on Revisiting the Food and Drug Administration (FDA) Approval of Aducanumab. Topics discussed include the Food and Drug Administration (FDA) granted accelerated approval to aducanumab (Aduhelm) for treatment of Alzheimer's disease; and the FDA made a late-stage decision to grant approval on the basis of aducanumab's ability to lower levels of beta-amyloid observable on positron-emission tomographic brain imaging.

The article discusses legal, practical and ethical issues involving investigational drugs and expanded-access system developed by the U.S. Food and Drug Administration (FDA). The system allows patients with serious conditions to receive investigational drugs before formal product approval. The regulation of expanded access is also discussed.