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.
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.
Collecting information about mean and median approval times for abbreviated new drug applications (ANDAs) is very difficult, time consuming and frustrating. We looked at the 31 approvals in June 2013 to see how the Office of Generic Drugs (OGD) was doing.
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.
Yesterday, the FDA released an update to its 2007 Questions and Answers document on Medical Foods. Interestingly, it is the new information in this document that has us scratching our heads about the implications of this revised draft document.
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.
In a safety communication late yesterday, the FDA warned the public about the potential for acetaminophen to cause a rare, potentially fatal skin condition called Stevens-Johnson Syndrome (SJS), toxic epidermal necrosis (TENS) and acute generalized exanthematous pustulosis (AGEP). The Agency discovered this through evaluation of the literature and a search of its Adverse Events Database.
FDA announced the Fiscal Year 2014 User Fees to begin on October 1, 2013. This rise in fees was expected since the number of ANDA projected to be submitted in 2013 appears as if it may drop below the 1103 submitted in 2012. In addition, the number of facilities self-identifying was slightly lower than anticipated. Also remember that, in year one of GDUFA, there was $50 million of the $299 million permitted for 2013 associated with backlog fees to address the logjam of ANDAs in the backlog. That was a one- time fee which must now be made up by increases in the ongoing yearly fees.
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).
In a Federal Register notice published today, the FDA outlined the new fiscal year Prescription Drug User Fees.
FDA published its final Guidance to Industry – Safety Labeling Changes – Implementation of Section 505(o)(4) of the FD&C Act on July 30, 2013. Section 505(o)(4) (enacted under the FDAAA in 2007) gave the FDA new authority to require NDA, BLA and ANDA applicants for which there is no corresponding NDA to make certain label changes if there is new information available relative to safety issues. That new safety information may impact or require a Boxed Warning, changes to the Contraindications, Adverse Event or Warnings sections of the labeling. It could also require a change to a REMS program or patient information sheet.