Simplifying Global Compliance
Articles Tagged with ''computer''
The European Medicines Agency (EMEA) has published five product-specific final industry guidelines for the development of biogenerics — a move that comes as European regulators are expected soon to approve their first generic biologic. Read More
The FDA will cohost a workshop in May that aims to help drugmakers implement broad new requirements for pharmaceutical product labeling. Read More
The FDA has announced a public comment period on its renewed requirement that labeling content for prescription drug and biological products be submitted electronically, in a form the agency can process, review and archive. Read More
The FDA has announced a shortage of albuterol metered-dose inhalers containing both chlorofluorocarbons (CFCs) and the nonozone-depleting propellant hydrofluoroalkane (HFA). Read More
GlaxoSmithKline (GSK) has attached radio frequency identification (RFID) tags on all bottles of its HIV treatment Trizivir distributed in the U.S. Read More
Radio frequency identification (RFID) tags remain the primary technology for pharmaceutical firms seeking to combat counterfeiting, but other technologies could provide some competition, according to experts at a recent conference. Read More
High frequency (HF) radio frequency identification (RFID) tags are preferable to their ultra-high frequency (UHF) counterparts in combating counterfeiting or diversion of pharmaceutical products, a new study finds. Read More
Inadequate manufacturing processes are a main reason for slowdowns in the drug pipeline, according to a senior FDA official who notes that solving the problem will require greater emphasis by industry and changes to the agency’s good manufacturing practices (GMP) regulations. Read More
Success in moving investigational new drug (IND) projects toward adopting the electronic common technical document (eCTD) for electronic submissions is more about collaboration than technology, experts said at a recent industry gathering. Read More
Procter & Gamble (P&G) applies a proactive risk-assessment process on both a regulatory and operational level, a P&G manager said. Read More
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