U.S. lawmakers may have gained some time in their race against the clock to pass the FDA Reauthorization Act (FDARA), which sets drug and device user fees for the next five years. FDA officials reportedly indicated that the agency would hold off on issuing the 60-day furlough notices to employees whose positions are funded by the fees. Congressional leaders had hoped to get the bill to the president before breaking for the August recess, so the FDA would not have to begin sending the notices to more than 5,000 employees to notify them that they could lose their job in 60 days if the fee package isn't renewed by Sept. 30. The House passed FDARA earlier this month, but bickering over health care reform legislation has stalled the bipartisan user fee bill in the Senate. (See BioWorld Today, May 18, 2017, and July 13, 2017.

While the next user fee package is making its way through Congress, the FDA is still finalizing guidance on the current user fee legislation passed in 2012. The latest guidance is a Q&A document on generic drug user fees that's slated for publication in Wednesday's Federal Register. Finalizing a draft version released in 2013, the guidance answers questions on the self-identification of generic drug facilities, sites and organizations; the review of generic drug submissions; and inspections and compliance.

The EMA revised its guidance on first-in-human clinical trials to help stakeholders better identify and mitigate risks for trial participants. The guideline, issued Tuesday, emphasizes the sponsor's responsibility to define uncertainties associated with a drug candidate at each step of development and to describe how it intends, within the design and conduct of the trial, to address potential risks that arise. Sponsors must support their approach with a well-documented scientific rationale from the outset of development and be responsive to data emerging over the course of the trial, the EMA said. Reflecting the growing complexity of trial protocols, the revision refers specifically to the calculation of the starting dose, subsequent dose escalations and the criteria for the maximum dose. It also provides criteria on stopping a study, doing a rolling review of emerging data with special reference to safety information, and handling adverse events in relation to the trial's stopping rules and rules guiding dose escalation.

India's Central Drugs Standard Control Organisation (CDSCO) publicly posted a list of drug manufacturers with more than five drug samples that failed quality testing in the National Drug Survey. Leading the list of 66 manufacturers is Unicure India Ltd., which had 61 failed samples, according to CDSCO. Pfizer Ltd. plants in India are No. 11 on the list with 25 failed samples, and Dr. Reddy's Laboratories Ltd. is No. 36 with nine failed samples. The full report of the National Drug Survey is available separately on the CDSCO website.

In an unusual verdict in the first test case involving Androgel, a U.S. federal jury didn't hold Abbvie Inc., of North Chicago, liable for compensatory damages or negligence Monday, but it hit the drug company with $150 million in punitive damages for fraudulent misrepresentations of the testosterone replacement therapy. Jesse Mitchell v. Abbvie Inc. is one of six bellwether trials stemming from Androgel injury claims scheduled in the U.S. District Court for the Northern District of Illinois. If the verdict is not overturned on appeal, it could set a new standard by which fraudulent misrepresentations would not have to be tied to an injury linked to the drug.

The FDA issued safety recommendations on the acceptable amounts of two residual solvents in pharmaceuticals. Prepared under the auspices of the International Council for Harmonisation, the recommendations include a new permitted daily exposure (PDE) for triethylamine and a revised PDE for methylisobutylketone, according to a notice in Tuesday's Federal Register.