FDA to Publish ALL Comments Submitted by Individuals to Dockets on Regulations.gov
Well, as someone who routinely reviews regulations.gov postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through. Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to […]
Frances M. Zipp is new President, Consulting Operations for Lachman Consultants
Frances (Fran) M. Zipp has been selected by the Board of Directors of Lachman Consultant Services to be President effective March 3, 2014
Leon Lachman is Recipient of Lifetime Achievement Award
Lachman Consultant Services, Inc. is proud to announce that Dr. Leon Lachman received a lifetime achievement award from Long Island University’s College of Pharmacy.
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assertion that it has the authority to take photographs during on-site inspections, as clarified in recently issued draft guidance, is coming under challenge by drug industry counsel.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.
