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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 authors reflect on a proposal from the U.S. Food and Drug Administration which would change its rules governing pharmaceutical promotion and would widen the ability of drug manufacturers to distribute information on unapproved uses of their products. They suggest that research done on promotional statements has shown that some drug manufacturers have depicted the risks and benefits of their products inaccurately. They argue that off label promotion may impede rigorous scientific study.

The article offers information on the 21st Century Cures Act which was approved by the U.S. House of Representatives. Topics include the bill's ability to push for the development of new drugs, possible increases in the budget of the National Institutes of Health (NIH), and the establishment of the NIH Innovation Fund. It also discusses the need for the faster approval for new drugs, the involvement of the Food and Drug Administration (FDA), and the use of adaptive trial designs.

The article discusses the U.S. Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA). The Act extends user fees to generic drugs manufacturers in order to offer greater funding for FDA's generic-drug reviewers. It ensures that FDA will receive the user-fee funding that it needs to help promote review efficiency. However, the author argues that the ACT failed to promote more robust postmarketing systems to validate the effectiveness and safety of marketed products.

The article discusses the substantial role of social media Web sites in the marketing of pharmaceutical products, as well as the need to regulate such media advertising to ensure the safety of the consumers who access information on such media. It cites the efforts being done by the Food and Drug Administration (FDA) to monitor the drug labels of various products as a tool to protect the public's health. It presents the seal of approval that was introduced by the American Medical Association (AMA) to authenticate the information.

In this article, the author expresses his views on issues related to the decision made by the U.S. Food and Drug Administration (FDA) to grant market exclusivity to URL Pharma for the colchicine drug. Colchicine is a drug manufactured by URL Pharma for the treatment of acute flares of gouty arthritis. Information on the 1938 Food, Drug, and Cosmetic Act is also presented.

The article discusses the U.S. Supreme Court case of Wyeth V. Levine regarding liability protection for pharmaceutical manufacturers based on the approval of a drug's label by the U.S. Food and Drug Administration (FDA). The FDA argued that preemption could extend to health care practitioners. The author explains the relationship between product liability and medical malpractice. He believes that it would be unlikely that preemption would lead to new avenues of liability for physicians.

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 reports that legislation permitting the U.S. government to negotiate Medicare drug prices has been weakened after pushback from the pharmaceutical industry. Topics include government's costs for filling prescriptions in federal programs; and medications by means of the National Institutes of Health (NIH) to fund biomedical research.

A response from the authors of the Perspective article on the 21st Century Cures Act published in the June 25 issue is presented.

The article presents the Watchman Left Atrial Appendage Closure System designed as the most intensely studied device for thromboembolic prophylaxis in patients with nonvalvular atrial fibrillation. Topics discussed include a Food and Drug Administration (FDA) advisory committee review of findings from manufacturing, bench and clinical testing of the device and the importance of timely data on real-world experience to complement clinical-trial evidence to understand a technology like Watchman.

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 comments on the dispute over the U.S. Food and Drug Administration's (FDA) proposal to remove metastatic breast cancer indication from the label of Genentech's Avastin (bevacizumab). It considers the question of whether the standard for conversion of accelerated to regular approval in the case of bevacizumab has been met. It discusses the implications of the dispute for the credibility of the FDA and Genentech.

The article discusses the easing of the U.S. Food and Drug Administration (FDA) rules on statements regarding medications and dietary supplements as with the First Amendment clause of the U.S. Constitution. Topics covered include the Amarin Irish pharmaceutical company lawsuit against the FDA on the statement restrictions on its prescription fish oil, the Washington Legal Foundation advocacy and the guidelines by the American College of Cardiology as well as the American Heart Association.

The article discusses the Regulatory Accountability Act of 2017 which is passed by the U.S. Congress to reverse the increasing volume of regulatory requirements related to federal health policy. It mentions the revision of the 1946 Administrative Procedure Act that set ground rules for federal agency regulation. It notes the draft guidance issued by the U.S. Food and Drug Administration that allow any person to clarify governmental requirements and update outdated rules.

The article focuses on the implications of high-cost generic drugs on patients and policymakers in the U.S. Topics discussed include the need for the Food and Drug Administration (FDA) to create a way to promote competition and allow private market to function effectively, standard processing of generic drug approval, link of generic drug shortage with increase in price, and importance of implementing regulation to reduce price of older generic drugs.

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 article discusses challenges facing the U.S. Food and Drug Administration (FDA) in regulating mHealth or the use of mobile devices such as smartphones and tablet computers to improve health. Topics addressed include proposed bills in the U.S. Congress to change FDA jurisdiction over mHealth products, mHealth's clinical utility and risks, the FDA's plan to focus on mHealth's intended functionality and not the mobile platform, and the FDA's framework for mobile software.

The article discusses the implications for patients of the creation of breakthrough therapy in the U.S. Food and Drug Administration Safety and Innovation Act to ensure the safety and effectiveness of marketed prescription drugs. Topics include prior government efforts to expedite the availability of new therapeutics, the benefits and risks of expanded access and early approval, and the rationale and potential outcomes of breakthrough therapy.

The article compares the medical device regulations in the U.S. and the European Union (EU). High-risk device manufacturers in the U.S. are required by the Food and Drug Administration (FDA) to demonstrate safety and effectiveness before they can market their products. In Europe, patients have access to high-risk medical devices such as replacement joints and coronary stents. Criticisms against the EU system for conflicts of interest in its evaluation process are discussed.

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 offers information on the Risk Evaluation and Mitigation Strategy (REMS) created by the U.S. Food and Drug Administration Amendments Act (FDAAA). Topics include its aim to handle drugs with safety issues, the proliferation of REMS programs on generic drug manufacturers, and the Tracleer Access Program. It also discusses the patenting of the System for Thalidomide Education and Prescribing Safety that was developed by drug manufacturer Celgene.

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.

A letter to the editor is presented on the Perspective article on the 21st Century Cures Act by Avorn and Kesselheim published in the June 25 issue.

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.

Letters to the editor are presented in response to the article about the drug development programs of the U.S. Food and Drug Administraton (FDA) and its implications for patients, which appeared in the March 27, 2014 issue.