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  Indian pharma sees considerable applicability to US FDA’s norms on amount of listed drugs & biological products,   November 13, 2021
  Indian pharma considers US FDA norms on real-world data for EHR & medical claims will aid regulatory decisions,   October 28, 2021
  Industry views US FDA’s revised draft biosimilar development & BPCI Act as relevant to current needs,   September 30, 2021
  Indian pharma sees ICH Q12 for FDA-regulated products to help ascertain product quality risk,   September 18, 2021
  UF FDA to decide on forfeiture of 180-day exclusivity for ANDA on case-by-case basis,   September 13, 2021
  Indian pharma underscores need for US FDA guidance on Drug Supply Chain Security Act,   August 30, 2021
  India supply chain cos acknowledge importance of US FDA draft norms on drug distribution security at package level,   August 03, 2021
  Bio-pharma industry sees US FDA norms on BCS based bio-waivers to accelerate drug development,   June 14, 2021
  Indian pharma sees US FDA Q12 guidance as well-defined pathway for regulatory submission,   May 31, 2021
  Indian pharma sees US FDA norms for manufacture & inspections appropriate as virtual audits take centre-stage,   May 20, 2021
  Ophthalmologists see US FDA guidance on dry eye drug development to provide high quality therapy success,   February 02, 2021
  Indian clinical trial sector sees US FDA new norms in BE studies for ANDAs to ensure patient safety & data integrity,   January 23, 2021
  US FDA issues final guidance for Consumer Antiseptic Rubs, Indian exporters in sync with norms,   January 19, 2021
  US FDA works to provide clarity on new drugs in an age of personalized medicine,   January 14, 2021
  Indian pharma sees regulatory submissions in electronic format to ease risk assessment and allow speedy approvals,   January 05, 2021
  Industry sees relevance of US FDA norms on DDT as COVID-19 drug & vaccine research and approvals gather pace,   December 15, 2020
  US FDA’s draft norms on submissions for post-marketing requirements to enable industry to put systems in place,   November 10, 2020
  Industry sees relevance in US FDA’s draft norms on PMS as slew of COVID-19 drugs enter market,   October 27, 2020
  New US FDA guidance on ANDA to benefit Indian cos to get faster generic drug approvals,   October 05, 2020
  Industry sees US FDA draft labelling norms on geriatric information valuable,   September 24, 2020

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