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Medical Devices › Pharmaceutical Industry › FDARA

King & Spalding

FDA Warns Drug & Device Firms Against Delaying & Limiting Facility Inspections in New Draft Guidance

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On December 16, 2022, the U.S. Food & Drug Administration (“FDA” or “Agency”) published an important and noteworthy draft guidance document entitled “Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a...more

Hogan Lovells

FDA proposes a process for receiving nonbinding feedback on an establishment's response to an FDA Form 483

Hogan Lovells on

On 19 February 2019 the U.S. Food and Drug Administration (FDA or the agency) released a draft guidance entitled, "Nonbinding Feedback After Certain FDA Inspections of Device Establishments" (draft guidance) for comment. ...more

Mintz

NDA/ANDA Holders Must Affirmatively Submit Data to FDA or Risk Losing Products’ Active Listing in The Orange Book

Mintz on

Pharmaceutical industry stakeholders know that drug prices, market competition, supply chain challenges, and shortages of critical drug products have been top of mind for policymakers in recent years. Among others tackling...more

Mintz - Health Care Viewpoints

FDA 2017 Year In Review: Therapeutic Products Energized by Cures Act, Bold Leadership

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As is the tradition here at Health Law & Policy Matters, towards the end of the year we take stock of what transpired in our respective industries and highlight important legal, regulatory, and business developments. For...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - September 2017

Arnall Golden Gregory LLP on

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Hogan Lovells

FDA Embraces Real-World Evidence in New Final Guidance

Hogan Lovells on

On August 31, 2017, the U.S. Food and Drug Administration (FDA) finalized its guidance document entitled, "Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices." The final guidance reiterates...more

Akin Gump Strauss Hauer & Feld LLP

FDA Implements a New “Concept of Operations” for Drug Inspections

Akin Gump Strauss Hauer & Feld LLP on

The Food and Drug Administration (FDA) has announced implementation of a new “concept of operations” that seeks to improve FDA’s oversight over pharmaceutical manufacturers. The concept of operations complements FDA’s program...more

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