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Food and Drug Administration is making changes to the requirements for monitoring, prescribing, dispensing, and receiving the schizophrenia medicine clozapine, to address continuing safety concerns and current knowledge about…severe neutropenia…There are two parts to the changes in the requirements for treating patients with clozapine. First, we have clarified and enhanced the prescribing information for clozapine that explains how to monitor patients for neutropenia and manage clozapine treatment. Second, we approved a new, shared risk evaluation and mitigation strategy called the Clozapine REMS Program…

...there are roughly 30 million Americans who suffer from a rare disease. And sadly, about 50% are children.. FDA…recently released a new resource for drug developers — a draft guidance document — designed to help them navigate the difficult and unique challenges of developing and bringing to market…drugs to treat rare diseases...document is intended to encourage drug developers to think early on in the process about all aspects of their program — and encourages careful planning which includes a foundation in strong science. Drug developers for rare diseases are often pioneers…this guidance as another important resource to help support their efforts.

The kerfuffle over Kim Kardashian's drug-promoting Instagram selfie is nothing new: As long as the agency has existed, it's had to figure out how to regulate drug advertisements in new forms of communication technology…The rise of social media has raised a parade of new questions for the agency: How is it supposed to monitor person-to-person pharmaceutical recommendations? Can something be considered an advertisement if it’s only 140 characters long? Who is responsible for the accuracy of tweets about a drug? But this isn’t the first time evolving technology has forced the FDA to rethink its role.

International Academy of Compounding Pharmacists submitted comments on the Food & Drug Administration's underestimated time and cost burden of reporting adverse events by 503B outsourcing facilities.

Pan Drugs received the Warning Letter…with the US Food and Drug Administration citing a number of deviations from GMP (good manufacturing practices) standards during an inspection of the Nandesari, Vadodara facility (India)…failed to maintain, repair, and keep clean its API manufacturing units,…holes in the walls and roof which allowed pigeons access near production equipment…gaps and holes in outside walls for piping and air ducts which allow contaminants to enter the building…We have given the commitment to stop all production while we renovate the facility,…

On August 7, 2014, Federal District Court …blocked the Food and Drug Administration from enforcing restrictions on the marketing and promotion of off-label use of the drug icosapent ethyl (Vascepa),..If the case heralds the future of jurisprudence, responsibility for the oversight of the truthfulness of pharmaceutical promotions may shift from the nation’s leading science-based regulatory agency, the FDA, to the courts. If it does, the market for medications in the 21st century may revert to a time of more claims and less evidence to guide clinical care… Judges should refrain from using the First Amendment to undermine core regulatory functions.

Food and Drug Administration is working to develop regulatory systems for diagnostics using next generation sequencing technologies…will cover "analytic performance evaluation standards" and "challenges in clinical validation of NGS tests."...We aim to ensure that these tests provide accurate, reproducible, and meaningful results relevant to a person's medical condition while continuing to foster innovation so that people who have access to the best available results generated by the most cutting-edge medical technologies."

President Obama nominated Robert Califf as the next commissioner of the Food and Drug Administration,...Califf has been deputy FDA commissioner for medical products and tobacco. Before that, he was founding director of Duke’s Clinical Research Institute, the world’s largest academic research organization….

A hard drumbeat of FDA complaints against more than two dozen companies in India for quality violations has affected 39 drugmaking facilities, creating an avalanche of remedial work that could take years and is steadily driving up medicine costs in the United States…FT (Financial Times) said it counted 6 Indian drugmakers that had manufacturing sites hauled up by the FDA…encompassing 27 companies…spate of massive product recalls.

Pacira Pharmaceuticals Inc….filed a lawsuit seeking a court order allowing it to promote its post-surgery pain drug, Exparel (bupivacaine), for a wide range of surgeries, which the Food and Drug Administration opposes…Pacira contends that its own marketing is not for off-label use…Exparel,… is approved for administration into the site of surgery to produce post-surgery pain relief…approval was based on studies of its use in bunionectomies and hemorrhoidectomies,…Pacira, however, has promoted it for use in all kinds of surgeries.