The FDA published draft guidance on metered dose and dry powder inhalers highlighting considerations for critical quality attributes. Source: Drug Industry Daily

The FDA issued a warning letter to McCallum Manufacturing for deficiencies in process validation and quality control after an inspection of the firm’s Barnsley, South Yorkshire facility. Source: Drug Industry…

In the latest addition to the swirl of opioid-related bills circulating on Capitol Hill, four senators introduced legislation to require the FDA to issue guidance on how breakthrough and accelerated…

Rep. Frank Pallone (D-N.J.) proposed new legislation on continuous manufacturing during a joint visit with FDA Commissioner Scott Gottlieb to Rutgers University on Monday to discuss the campus’ role in…

Disease-focused guidance and a new knowledge management platform are among the key initiatives in the FDA’s fiscal 2019 budget request of $5.8 billion, Commissioner Scott Gottlieb told the House Appropriations…

The FDA hit Optikem with a Form 483 after the agency’s investigator observed unsanitary conditions and problems with records in an inspection of the firm’s Denver facility. Source: Drug Industry…

Moves to increase clinical trial data transparency gathered momentum this week with the release by Vivli of the beta version of its clinical trial data-sharing platform to the public prior…

The FDA rescinded a refuse-to-file letter it issued to Alkermes in March for the company’s experimental treatment for depressive disorder, the company announced Monday. Source: Drug Industry Daily

The FDA announced a new pilot program in which drug sponsors can meet with agency officials to discuss strategies for model-informed drug development (MIDD) to make their clinical trials more…

Lannett filed an emergency petition with the FDA requesting postponement of the agency’s withdrawal order for its ANDA for Glycolax pending a court ruling. Source: Drug Industry Daily