In an ongoing crackdown on repackers, the FDA recently issued warning letters to three repackers of active pharmaceutical ingredients (API) for significant violations of current good manufacturing practice requirements.

The FDA's Center for Drug Evaluation and Research (CDER) issued 62% more warning letters under the first part of the Trump administration than it did during the last few years of the Obama administration. But the number of warnings for medical devices, food and tobacco products fell sharply under President Donald Trump, according to an investigative report being published in the July 5 issue of Science.

The FDA Monday released two draft guidances on the content and format of specific sections in prescription drug labeling. 

Cochlear Ltd., of Sydney, received U.S. FDA approval for its Nucleus Profile Plus cochlear implant and the Nucleus 7 sound processor's new built-in connectivity, enabling direct streaming with compatible Android smartphones. The implant will be commercially available in the U.S. later this month.