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Canadian Drug Importation May Undermine Intellectual Property Protection

The Situation: Earlier this year, Florida became the first state to receive authorization for its Section 804 Importation Program ("SIP") from the U.S. Food and Drug Administration ("FDA"). This initial step toward the legal...more

FDA Announces Proposed Rule Regarding Laboratory Developed Tests

The highly anticipated rule, which would make explicit that LDTs are medical devices subject to FDA oversight, proposes to end the agency's general enforcement discretion approach to such devices....more

Industry Anticipates Impending FDA Proposed Regulation Addressing Laboratory Developed Tests

Stakeholders prepare for the U.S. Food and Drug Administration's ("FDA") rulemaking effort to "make explicit" that laboratory developed tests ("LDTs") are devices subject to the agency's oversight, reigniting outstanding...more

Federal Agencies Launch New Websites Containing All Guidance Documents Still In Effect - Guidance documents not included on the...

This action implements a portion of the President's recent Executive Order 13891, "Promoting The Rule Of Law Through Improved Agency Guidance Documents." In that executive order, the President directed agencies to review...more

Protecting Against False Advertising of COVID-19 Molecular or Antibody Tests

The Background: Test manufacturers and labs are rushing to offer molecular and antibody tests for the novel coronavirus (COVID-19) to meet huge demand. Meanwhile, regulatory oversight during this national emergency has...more

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