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FDA

From FDA - Page 9
Agency pushes policies to promote generic competition for these drugs that by the nature of their formulation, delivery systems, or ingredient complexities, are more difficult to “genericize” and often face less competition.
FDA Plans to Advance Complex Generics
Valsartan / Image: Google
Carcinogens in Blood Pressure Drug Went Undetected for 4 Years
Vaper Vaping / Image: UCSF
The FDA Threatens to Pull E-Cigs From the Market
Agency updates its compounding priorities plan to address patient safety while revising cGMP draft guidance to make it more feasible for outsourcing facilities to fulfill requests for office stock while maintaining product quality.
FDA Focuses on Compounded Drug Quality; cGMPs for Outsourcing
HDA’s response to FDA’s Draft on DSCSA Product Identifiers identifies lack of time to respond. GTIN or NDC identifier, human-readable expiration date format also pose concerns.
Making a Plea for a Single Product Identifier
Fight Against AIDS / Image: BMC
FDA Increases Effort to Fight AIDS
Plastic grippers made via 3D printing. (Photo from igus.)
3D Printing Part of an ‘Unparalleled Period of Invention’
Two companies receive notifications from agency for selling products marketed as dietary supplements with known safety issues to patients seeking relief from medical conditions such as opioid abuse disorder.
FDA Sends Warning Letters Regarding Tianeptine
For sterile injectable drugs, NIPP is reported as the first in a planned series of new inspection protocols covering all dosage forms. Agency’s goal is for full implementation within two years.
FDA Announces New Inspection Protocol Project
Eric F. Greenberg
Tobacco pushes to the front of the line
President signs Support for Patients and Communities Act into law; HCPC applauds efforts of Congress and the FDA.
New opioid crisis law cites unit-dose packaging
President signs Support for Patients and Communities Act into law; HCPC applauds efforts of Congress and the FDA.
New Opioid Crisis Law Cites Unit-Dose Packaging
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