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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.
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.
The FDA has announced a shortage of albuterol metered-dose inhalers containing both chlorofluorocarbons (CFCs) and the nonozone-depleting propellant hydrofluoroalkane (HFA).
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.
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.
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.
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.