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FDA

From FDA - Page 11
Eric F. Greenberg
No Shortage of Creative Solutions
The FDA provided this image to identify what's different with the new Nutrition Facts label.
Dietary fiber update leads to first Nutrition Facts label overhaul in more than 20 years
Sunscreen Pills are Fake / Image: Tatyana Zenkovich
FDA Throws Shade at Sunscreen Pills
Commissioner Scott Gottlieb, MD, points to agency’s Drug Competition Action Plan and generic drug review process among its efforts ‘to put American patients first.’
FDA’s Gottlieb Comments on Trump Administration’s Plan to Lower Drug Prices
New eight-page draft guidance helps trading partners understand the process for requesting waivers, exceptions and exemptions from DSCSA product identifier requirements.
FDA: Guidance on DSCSA Waivers
Agency believes final order will decrease regulatory burden on manufacturers as they will no longer be required to submit a premarket approval application (PMA), but can instead submit a less-burdensome premarket notification (510(k)) before marketing this type of device. Shown here is a sharps collection container, not a needle destruction device.
FDA Reclassifies Sharps Needle Destruction Device
Compliance dates extended in effort to ensure that manufacturers have sufficient time to print updated labels. Agency to launch education campaign for consumers.
FDA issues final rules for both nutrition facts and serving sizes
CDER's Drug Safety Priorities 2017 report.
CDER Focuses on Drug Safety
Caffeine Supplements / Image: Bulk Supplements
FDA Warns Against Dietary Supplements with Too Much Caffeine
New action plan focuses on five key areas, including timely postmarket mitigations, cybersecurity and taking a Total Product Life Cycle approach to device safety.
FDA Modernizes Approach to Medical Device Safety and Innovation
In a review of 40 pharmaceutical dispensers, an OIG study shows that most received all drug product tracing details from their trading partners, but more work needs to be done.
New OIG Report Calls for FDA Education for Pharma Dispensers
FDA notes developing technologies, such as next-generation sequencing tests, that can scan a person’s DNA to detect genomic variations.
Modest Growth Predicted for IVD Market
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