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Pharmaceutical Industry › Food and Drug Administration (FDA) › Suppliers

Quarles & Brady LLP

FDA Announces Guidance for DSCSA Process to Request a Waiver, Exception, or Exemption

Quarles & Brady LLP on

On Friday, August 4th, the Food and Drug Administration (“FDA”) announced the availability of a final guidance document, titled “Waivers, Exceptions, and Exemptions From the Requirements of Section 582 of the Federal Food,...more

Goodwin

Field Alert Reporting: Supplier Contracting Implications for Drug Developers

Goodwin on

For emerging companies establishing their first supply chains, ensuring notification requirements in supply agreements for when commercial-stage manufacturing issues arise may not be top of mind. However, it is important for...more

Hogan Lovells

FDA explains how EUA medical devices can electronically comply with AE reporting requirements

Hogan Lovells on

On September 9, the U.S. Food and Drug Administration (FDA) updated its online FAQs, entitled “Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance...more

Searcy Denney Scarola Barnhart & Shipley

Compounding Pharmacies -- Are Users of Finasteride for Hair Loss in Danger?

Searcy Denney Scarola Barnhart & Shipley on

WHAT ARE THEY? Sometimes the needs of a patient are so unique that prescription medications readily available at retail drug stores are not sufficient to combat the illness or treat the condition. An example of such a...more

Troutman Pepper

Temporary FDA Policy for Compounding COVID-19 Drugs Poses Opportunities and Risks for Hospitals and Pharmacies

Troutman Pepper on

With COVID-19 cases on the rise in the United States, some hospitals have faced shortages of FDA-approved drug products used to treat the disease. ...more

Hogan Lovells

FDA moves to increase ventilator supply

Hogan Lovells on

Amid reported shortages of ventilators, accessories, and other respiratory devices resulting from the spread of novel coronavirus COVID-19, FDA issued a letter to health care providers and new guidance on 22 March 2020,...more

Goulston & Storrs PC

An Unintended Interruption to the Global Supply Chain

Goulston & Storrs PC on

The current outbreak of COVID-19 (the coronoavirus) will be a test of the global supply chain’s strength in the face of unintended interruptions, and can be a lesson on building-in supply-chain contingency plans.  As a result...more

Holland & Knight LLP

FDA Guidance on DSCSA Product Identifier Requirements

Holland & Knight LLP on

Members of the pharmaceutical supply chain, including drug wholesalers and manufacturers, are grappling with fast-approaching deadlines for compliance with new federal regulatory requirements. The Drug Quality and Security...more

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