In the Federal Register today, FDA announced a public meeting to be held on June 15, 2015 at the FDA’s White Oak campus. The purpose of the meeting is to get the public’s input on the potential reauthorization of the Generic Drug User Fee Act (GDUFA).
The FDA is warning about some counterfeit Botox that has been found in the United States. The product looks similar to the brand name product but “[B]oth the outer carton and vial on the suspect product are counterfeit.
Frances (Fran) M. Zipp has been selected by the Board of Directors of Lachman Consultant Services to be President effective March 3, 2014
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.
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.
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.
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).
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assertion that it has the authority to take photographs during on-site inspections, as clarified in recently issued draft guidance, is coming under challenge by drug industry counsel.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
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.