FDA China Inspection Expansion Stymied by Visa Holdup: Official
The FDA’s expansion into China is well underway, but additional inspectors are on hold because Chinese officials are not issuing visas to agency employees.
California Adopts ePedigree Regulations as 2015 Deadline Looms
The California Board of Pharmacy recently adopted regulations detailing what drugmakers, distributors and other stakeholders must do to meet a 2015 deadline under the state’s electronic pedigree law.
Expert Says Safety Labeling Guidance Debunks RLD Theory; PA Court Disagrees
The FDA’s final guidance on safety labeling changes, issued Tuesday, clears up any ambiguity about whether drugmakers can make changes to a generic drug’s label if that drug is designated as a reference listed drug (RLD).
FDA Aims to Secure Photo Rights Under FDASIA
The FDA’s assertion that it has the authority to take photographs during on-site inspections, as clarified in recently issued draft guidance, is coming under challenge by drug industry counsel. The agency constitutes refusal
Proposed Measures to Clarify FDA’s Import and Inspection Authority
The FDA moved to close a glaring gap in the agency’s import powers Friday, issuing a proposed rule that grants detention authority for drugs.
