The International Society for Pharmaceutical Engineering has launched a drug shortage assessment and prevention tool that helps drugmakers identify risks early on.
Fran Zipp, President of Lachman Consultants, presented at the 2015 ISPE Annual Meeting, November 8-11 at the Philadelphia Marriott Downtown. She spoke about the launch of the ISPE Drug Shortage Assessment and Prevention Tool, on Monday, November 9 at 10:45 AM. For a preview of the tool, please see this article authored by Fran in November’s issue of Pharmaceutical Engineering.
Lachman Consultants recently exhibited at BioProcess International Conference and Exposition at the Hynes Convention Center, Boston, MA.
Serving as a member of the pharmaceutical industry is a privilege that brings with it significant personal responsibility. In recent years, preventing and mitigating drug shortages has become a critical concern for every pharmaceutical professional. ISPE is leading an international effort to understand, assess, and educate patients, providers, regulators, and manufacturers on this critical topic.
Many of you reading this blog may not remember the Star Trek “Replicator”. In the Trek far future, members of the crew, when hungry, would simply walk up to this device and key in what they wanted to eat. The Replicator would then build a suitable, tasty meal by mixing the right combinations of materials.
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 regulations.gov,
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.