The iQue ® software module for 21 CFR Part 11 ensures next-level iQue ® productivity for regulated laboratories. Designed for speed and actionable results, iQue ® is the instrument of choice ...

See 21 CFR parts 11, 54, 210, 211, 312; the FDA Center for Drug Evaluation and Research; and UAB HRPP PRO121 Procedure to Ensure Handling of Investigational or Unlicensed Test Articles Meets ...

Analyses with Vision Air are completely traceable and meet the requirements of the FDA 21 CFR part 11 for the pharmaceutical industry. Vision Air is easy to command. Two clicks is all that is ...

The new director at the FDA overseeing medical devices will confront criticisms about hasty approvals as she ushers in ...

(RTTNews) - Biotechnology company Unicycive Therapeutics, Inc. (UNCY) announced Monday that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for Oxylanthanum ...

Watlow, a US-based industrial heating manufacturer, will preview its Eurotherm branded Edge Process Management platform at ...

In this context, Mr. Rohit Singhal emerges as a figure specializing in overseeing large-scale data migration projects (moving ...

Applications for proposed drug products where the rate (21 CFR 314.54(b)(2)) and/or extent (21 CFR 314.54(b)(1)) of absorption exceed, or are otherwise different from, the 505(j) standards for ...

The FDA has placed a trial of Rapport Therapeutics’ epilepsy drug for a type of nerve pain on hold while the biotech tweaks ...

Heat and Control, in Booths N-6104 and N-6106 at PACK EXPO International, will display its THS/PH210 Series metal detectors ...