2005

Regulatory Affairs

• Re: ISO vs GMP, Jay2rees
• New EU legal framework for harmonisation of the data exclusivity, Zdravko Mauko, FARMAVITA
• Seasons Greetings, A. D'Emanuele
• time frame for DMF, Ashish
  • <Possible follow-up(s)>
  • time frame for DMF, Zdravko Mauko, FARMAVITA
  • Re: time frame for DMF, Ashish Mohan
• Licensing and DMF, Ashish
• Assistance with obtaining journal articles that appeared over 10 years ago, Michael Anisfeld
• Re: Assistance with obtaining journal articles that appeared over 10 years ago, bruce berger
  • <Possible follow-up(s)>
  • Re: Assistance with obtaining journal articles that appeared over 10 years ago, Stanley110
• Re: BE Injectables, Marcio.O.Silva
• Authorized Generic, Naren
• Biowaiver in Canada, Nisha K R
  • <Possible follow-up(s)>
  • Re: Biowaiver in Canada, gitarao
• Data Exclusivity, Ashish
  • <Possible follow-up(s)>
  • RE: Data Exclusivity, Zdravko Mauko
  • Re: Data Exclusivity, Ashish NIPER
  • RE: Data Exclusivity, Steve Binysh
• 8+2+1 Data Exclusivity in EU, Zdravko Mauko, FARMAVITA
• Data Exclusivity in USA, Zdravko Mauko, FARMAVITA
• DMF holder can ?, Ashish NIPER
  • <Possible follow-up(s)>
  • RE: DMF holder can ?, Steve Binysh
  • RE: DMF holder can ?, Lassoff, Peter
  • RE: DMF holder can ?, Michael Anisfeld
  • RE: DMF holder can ?, Steve Binysh
  • RE: DMF holder can ?, Lassoff, Peter
• Injectable Grade Regulatory Requirements, durgabp
  • <Possible follow-up(s)>
  • Re: Injectable Grade Regulatory Requirements, lt09
  • RE: Injectable Grade Regulatory Requirements, Michael Anisfeld
• API GMPs: ICH-Q7A, Michael Anisfeld
  • <Possible follow-up(s)>
  • RE: API GMPs: ICH-Q7A, Peter Geffen
  • RE: API GMPs: ICH-Q7A, Michael Anisfeld
  • RE: API GMPs: ICH-Q7A, Lassoff, Peter
  • RE: API GMPs: ICH-Q7A, lt09
  • RE: API GMPs: ICH-Q7A, Lassoff, Peter
  • RE: API GMPs: ICH-Q7A, lt09
  • RE: API GMPs: ICH-Q7A, Michael Anisfeld
• EU identification of packages, stein
• rapid microbiology method for sterility testing, Nimrod
• Generic applications via Centralised Procedure, Vincent Kuanyin Agoth Wek
  • <Possible follow-up(s)>
  • Re: Generic applications via Centralised Procedure, lt09
  • RE: Generic applications via Centralised Procedure, Steve Binysh
  • RE: Generic applications via Centralised Procedure, Lassoff, Peter
  • Re: Generic applications via Centralised Procedure, arvinda
• re API GMPs: ICH-Q7A - Audit of Suppliers, Andrew Downing
• Re: API GMP audit--Michael Ansfield Question, alanlongworth
• Import of drugs to India, Jayram ramesh
• Solution,Syrups and Suspension, yash wardhan
• BA/BE across regulated markets, Nisha K R
• CTD Module 1, Shalaka Mishra
  • <Possible follow-up(s)>
  • RE: CTD Module 1, Tim Felgate
  • Re: CTD Module 1, lt09
• impurities in drug product., A. D'Emanuele
  • <Possible follow-up(s)>
  • RE: impurities in drug product., Steve Binysh
• Regulatory Publications, Nisha K R
  • <Possible follow-up(s)>
  • RE: Regulatory Publications, Tim Felgate
• Gamma Irradiation of API, Michael Anisfeld
• OTC Monograph, thirumurugan gopalasamy
  • <Possible follow-up(s)>
  • Re: OTC Monograph, arvinda
• API - Date of Manufacture, Michael Anisfeld
  • <Possible follow-up(s)>
  • Re: API - Date of Manufacture, Theodor Poettinger
  • RE: API - Date of Manufacture, snair
  • RE: API - Date of Manufacture, snair
  • RE: API - Date of Manufacture, Theodor Poettinger
  • RE: API - Date of Manufacture, Theodor Poettinger
  • RE: API - Date of Manufacture, snair
  • Re: API - Date of Manufacture, Brian MATTHEWS
  • RE: API - Date of Manufacture, Michael Anisfeld
• Stability data 505(b)(2) NDA, Michael Beckert
• Change of Servers this weekend, PharmWeb-Admin
• RE: Sunscreen Products, David
  • <Possible follow-up(s)>
  • Sunscreen Products, Michael Anisfeld
  • RE: Sunscreen Products, Lassoff, Peter
  • RE: Sunscreen Products, Lassoff, Peter
  • RE: Sunscreen Products, Michael Anisfeld
  • RE: Sunscreen Products, bruce berger
  • RE: Sunscreen Products, Michael Anisfeld
• Test methods of Inactive ingredients in ANDA, Nisha K R
  • <Possible follow-up(s)>
  • Re: Test methods of Inactive ingredients in ANDA, bruce berger
• FDA inspection of foreign OTC manufacturing facilities, Bahirathan Mahesan
  • <Possible follow-up(s)>
  • Re: FDA inspection of foreign OTC manufacturing facilities, bruce berger
• Process Validation, thirumurugan gopalasamy
• Re: Impurity Qualification, arvinda
• Bioeq CRO Inspection - Brazilian Legislation, Marcio.O.Silva
  • <Possible follow-up(s)>
  • Re: Bioeq CRO Inspection - Brazilian Legislation, Marcio.O.Silva
• Batch Definitions, Michael Anisfeld
  • <Possible follow-up(s)>
  • RE: Batch Definitions, Steve Binysh
  • RE: Batch Definitions, Steve Binysh
• API expiry question, Eden Venti
  • <Possible follow-up(s)>
  • Re: API expiry question, kuntal chatterjee
  • Re: API expiry question, Nisha K R
  • Re: API expiry question, Brian MATTHEWS
  • Re: API expiry question, Nisha K R
  • Re: API expiry question, Brian MATTHEWS
  • RE: API expiry question, Lassoff, Peter
• ANDA Package insert related query, vardhini kirthivas
  • <Possible follow-up(s)>
  • RE: ANDA Package insert related query, Peter Rais
  • Re: ANDA Package insert related query, bruce berger
  • RE: ANDA Package insert related query, kalpana m dhumal
• FDA Stability Guideline, Marcio.O.Silva