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.
In an FDA Safety Alert issued today, the FDA warned of potentially serious liver failure that can result in need for liver transplant, or death and adrenal insufficiency that has been observed with Nizoral (ketoconazole) tablets. This pertains to both the brand and generic versions of the tablet form of the drug.
In a Federal Register Notice to publish today, the FDA is issuing a direct Final Rule that eliminates the destruction of certain turtle eggs and turtles less than 4 inches by or under the supervision of an FDA investigator (see FR notice here).
The original regulation with was designed to stop the spread of turtle-related salmonellosis (particularly to children) banned the sale or possession of certain turtle eggs or live turtles with a carapace length of less than 4 inches.
, what is a PLAIR? It stands for Pre-Launch Activities Importation Request. Over the last few years, the FDA had issued some informal directions in the form of an instructions sheet and a Question and Answers document. Today the contents of those documents have been incorporated into a Draft Guidance
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
