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January 15, 2020
Tracking and implementing label changes are crucial to the lifecycle of a marketed drug product.
January 03, 2020
The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.
January 02, 2020
Pressures on FDA will affect industry’s success in bringing new therapies to market.
FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.
Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.
In 2020, European regulators are expected to start to be even more active in encouraging drugs innovations rather than hindering them through legal restrictions.
As a new decade has begun, this editorial reviews some of the biggest, brightest, and boldest happenings from the industry over the past 10 years.
Regulatory mandates, niche diseases, and patient-centric solutions have all impacted pharma packaging over the years and are expected to help shape the future of the sector.
Without careful consideration and understanding, new regulations for medical devices could lead to the withdrawal of combination products from the market.
December 18, 2019
The guidance describes procedures for obtaining an additional National Drug Code for prescription drugs imported into the United States.