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FDA

From FDA - Page 15
Agency’s effort aims to help ensure CRP statements on drug labels are clear, useful, informative and consistent.
FDA Releases Guidance on CR Packaging
FDA combines with international partners to create a new supply chain security toolkit that covers everything from raw materials to patient use. (Photo from FDA website.)
Securing the Supply Chain from Substandard and Falsified Drugs
Healthcare Distribution Alliance CEO says primary pharmaceutical distributors play critical role in mitigating ‘the nation’s opioid abuse epidemic.’
All Supply Chain Stakeholders Needed to Address Opioid Abuse
FDA issued a June 30 draft guidance document that delays enforcement until Nov. 26, 2018 of DSCSA product identifiers at the package level. (Photo supplied by Adents).
FDA issues one-year delay in DSCSA product identifier enforcement
FDA issued a June 30 draft guidance document that delays enforcement until Nov. 26, 2018 of DSCSA product identifiers at the package level. (Photo supplied by Adents).
FDA Issues One-Year Delay in DSCSA Product Identifier Enforcement
FDA / Image: Reuters
FDA Increases Speed to Market for Rare Disease Drugs
Certain drug formulations may deter abuse, such as those that make crushing or liquefying for injection more difficult.
Opioid Epidemic: FDA to Hold Public Meeting
For lower risk devices, new compliance dates will extend into 2020 and 2024.
FDA: Delayed UDI Compliance Dates for Class I and Unclassified Devices
Generally, manufacturers protect products when shipping to the wholesalers, but one veteran pharmacist says that’s not always the case on the journey from the specialty pharmacy to the patient, depending on the pharmacy.
The Not-So-United States of Cold Chain
Dr. Scott Gottlieb, FDA Commissioner, establishes an Opioid Policy Steering Committee, raising prescription and policy questions. Source: FDA
FDA Commissioner: ‘More Forceful Steps’ Needed to Stem the Opioid Crisis
Eric Greenberg, Contributing Editor
With new FDA head, expect activism
Eric Greenberg, Contributing Editor
With New FDA Head, Expect Activism
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