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The FDA is preparing to release a draft guidance that will contain details about a new investigational new drug (IND) application process that it hopes will enhance post-discovery drug development, according to a top agency official.
The FDA is preparing to release a draft guidance that will contain details about a new investigational new drug (IND) application process that it hopes will enhance post-discovery drug development, according to a top agency official.
The Good Automated Manufacturing Practice (GAMP) Forum, a division of the International Society for Pharmaceutical Engineering (ISPE), has released its "GAMP Good Practice Guide: A Risk-Based Approach to Compliant Electronic Records and Signatures."
The FDA has issued a guidance document that informs certain medical device manufacturers about performing studies to support modifying the indication for use of communicable disease tests to include testing of cadaveric blood specimens to screen donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps).
The FDA has announced the availability of final guidance for industry on how to conduct a safety review of a new drug application (NDA) and a biologics license application (BLA).
The standards ANSI/AAMI SP9-1994 and ANSI/AAMI SP10-1992 for blood pressure measurement devices have been recognized by the FDA in a new draft guidance as standards for the purpose of premarket clearance.
Purdue Pharma of Stamford, Ct., has purchased 100 mobile radio-frequency identification (RFID) systems that it plans to donate to law enforcement and cargo-theft investigative agencies to fight drug counterfeiting, Purdue and Symbol Technologies, a Holtsville, N.Y.-based mobile technology vendor, announced Feb. 14.
The FDA published a new draft guidance Feb. 14 that provides recommendations on how the public, including industry representatives, may participate in open public hearing sessions conducted as part of advisory committee meetings.
Sponsors intending to submit a new drug application (NDA) or biologic license application (BLA) related to agents designed to help rid the body of radiological contamination from a terrorist attack or accident should consult with FDA officials prior to making their submissions — especially if they intend to seek approval under the Animal Efficacy Rule.
The Centers for Medicare & Medicaid Services (CMS) issued a final decision memorandum that will lead to reimbursement for a broad range of oncology studies in which positron emission tomography (PET) with fluoro-2-deoxy-D glucose (FDG) is used, increasing cancer patients’ access to this therapeutic agent and improving the diagnosis and treatment of cancer patients nationwide.