Publications

Hogan Lovells Publications

FDA finalizes 3D printing guidance

On December 5, 2017, the U.S. Food and Drug Administration (FDA or the Agency) finalized its “leapfrog guidance” entitled, “Technical Considerations for Additive...

Publications

FDA seizes stem cell cherapy — A first of many?

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for...

Publications

FDA, EU regulators agree to share unredacted inspection reports and other confidential information

The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the European Commission – DG Sante (DG Sante), signed a new confidentiality commitment which...

Hogan Lovells Publications

The more the merrier: Knowing when, why, and what to tell FDA about combination product postmarket events

The FDA announced yesterday that it is issuing final regulations governing postmarketing safety reporting for combination products. The regulations become effective January 19, 2017, but...

Hogan Lovells Publications

FDA Announces Major Proposed Rule Amending Hatch-Waxman Regulations

On February 6, 2015, the Food and Drug Administration (FDA) published in the Federal Register (FR) a comprehensive proposed rule (80 FR 6802) to amend agency regulations governing...

Hogan Lovells Publications

FDA Issues Proposed Rule to Implement Its New Authority to Destroy Drugs Valued at $2,500 or Less That Are Refused Import Into the U.S.

On May 6, 2014, the FDA issued a proposed rule to implement the agency's new administrative authority to destroy drugs valued at $2,500 or less that have been refused admission during...

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