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Regulatory Affairs


02 January, 2003
11:18 Seasons Greetings A. D'Emanuele

06 January, 2003
08:02 ANDA Vimal Patel

10 January, 2003
14:50 BSE/TSE vim_1008

12 January, 2003
12:05 Re: BSE/TSE lt09

06 February, 2003
07:40 Named Patient supplies - EU Iftikhar Saiyed
12:39 RE: Named Patient supplies - EU Lassoff, Peter
17:57 RE: Named Patient supplies - EU Lassoff, Peter

20 February, 2003
11:24 Brazilian Drug master file SUDESH MEHTA

21 February, 2003
08:41 Incidence of extra peaks Dpcox
16:03 RE: Incidence of extra peaks Bales, Frank
18:55 Re: Incidence of extra peaks Dennis Fleming
21:05 RE: Incidence of extra peaks Tom McMahon

24 February, 2003
18:53 contents of Modules 4 & 5 of CTD Mona Gogia
18:53 choice of reference product Mona Gogia
21:58 RE: choice of reference product Lassoff, Peter

25 February, 2003
12:52 IIG counterpart in Europe Mona Gogia
12:53 Exhibit batch size requirements for non-oral generics Mona Gogia
13:37 Re: Exhibit batch size requirements for non-oral generics Brian MATTHEWS
13:38 Re: IIG counterpart in Europe Brian MATTHEWS

26 February, 2003
07:57 CTD fromat for applications to US, EU & JAPAN Thirumurugan G (Regulatory Affairs)
17:42 Re: CTD fromat for applications to US, EU & JAPAN lt09

27 February, 2003
06:33 Re: Exhibit batch size requirements for non-oral generics mona gogia
06:33 Re: CTD fromat for applications to US, EU & JAPAN mona gogia
14:44 Re: Exhibit batch size requirements for non-oral generics lt09
17:05 Clinical Trials Directive Bell, Sarah (SLH)

28 February, 2003
08:05 schedule of FDA negative reports ERWINRF
10:27 RE: schedule of FDA negative reports Rick Flora
15:06 Re: schedule of FDA negative reports Dpcox

03 March, 2003
12:41 Contents of module 4 & 5 Mona Gogia

04 March, 2003
07:40 RE: Contents of module 4 & 5 Thirumurugan G (Regulatory Affairs)

05 March, 2003
08:54 Residual solvents -Inhouse surit
11:24 Re: Residual solvents -Inhouse Brian MATTHEWS
13:12 Excipients Brian MATTHEWS

06 March, 2003
07:46 Re: Excipients mona gogia
09:01 Re: Excipients Theodor_Poettinger
11:03 Re: Excipients Brian Matthews
11:03 Re: Excipients Brian Matthews
13:16 Reference product in BE for marketing authorisation Mona Gogia
14:14 RE: Reference product in BE for marketing authorisation Lassoff, Peter
14:14 Re: Reference product in BE for marketing authorisation Brian Matthews
14:34 Re: Reference product in BE for marketing authorisation Bulcsu Herenyi

07 March, 2003
18:29 RE: Reference product in BE for marketing authorisation mona gogia
18:30 Re: Reference product in BE for marketing authorisation mona gogia
18:30 IPEC GMP CERIFICATE surit

08 March, 2003
13:15 Re: IPEC GMP CERIFICATE Brian MATTHEWS
13:15 Re: Reference product in BE for marketing authorisation Brian MATTHEWS

09 March, 2003
12:18 Re: IPEC GMP CERIFICATE HoroRL

10 March, 2003
09:33 RE: Reference product in BE for marketing authorisation Lassoff, Peter
13:50 European Pharmacopoeia Jeannette Westergaard
15:20 Re: European Pharmacopoeia Brian MATTHEWS
15:21 Re: European Pharmacopoeia sreedhare
15:21 RE: European Pharmacopoeia Lassoff, Peter

14 March, 2003
11:54 TSE/BSE anu sree
12:56 RE: TSE/BSE Lassoff, Peter
14:24 Re: TSE/BSE Brian MATTHEWS
14:49 AW: TSE/BSE Giebel, Alexander {BD~Penzberg}
15:30 Re: AW: TSE/BSE Bulcsu Herenyi
16:06 RE: AW: TSE/BSE Lassoff, Peter
16:07 Re: TSE/BSE Brian MATTHEWS
18:38 Re: AW: TSE/BSE Brian MATTHEWS

17 March, 2003
07:56 Common mfg facility for animal and human drug products monagogia
09:25 Re: AW: TSE/BSE Bulcsu Herenyi
12:57 Re: Common mfg facility for animal and human drug products marne.platt

18 March, 2003
10:13 Re: Common mfg facility for animal and human drug products mona gogia
16:03 Analytical methods validation "Cristina Blanco Fernández"
16:21 RE: RegAffairs Digest - 18/03/03 Jeff Hirschorn
20:20 Re: AW: TSE/BSE Brian MATTHEWS

19 March, 2003
09:36 Re: AW: TSE/BSE Bulcsu Herenyi
10:03 address prasanna sagar
10:21 Re: AW: TSE/BSE Gordon.Urquhart
17:08 Re: AW: TSE/BSE Brian Matthews
17:09 Re: address Bulcsu Herenyi
17:12 RE: address Vig, Indy
17:12 Re: re: address Henrik Westerlind
17:29 RE: address Lassoff, Peter
17:29 RE: address Globepharm /MAnisfeld

20 March, 2003
11:01 Exclusivity data prasanna sagar
11:01 Biostudy prasanna sagar
12:48 Re: Biostudy Brian MATTHEWS
12:48 Re: Exclusivity data Brian MATTHEWS

21 March, 2003
13:00 Re: Exclusivity data prasanna
13:00 SD pork liver prasanna sagar
13:00 INNOVATOR BRANDS prasanna sagar
14:23 Re: Exclusivity data Brian MATTHEWS
14:23 Re: INNOVATOR BRANDS Brian MATTHEWS
14:25 Re: SD pork liver Brian MATTHEWS

26 March, 2003
07:44 USDMF SUDESH
09:33 EDMF and CEP Mona Gogia
09:57 RE: USDMF Lassoff, Peter
09:59 RE: EDMF and CEP Lassoff, Peter
09:59 Re: EDMF and CEP Bulcsu Herenyi
18:55 Barcodes Italy and Belgium stein

27 March, 2003
08:35 overfill rate determination Lawrence
09:43 RE: Barcodes Italy and Belgium Lassoff, Peter
09:45 SPC prasanna
21:57 RE: Barcodes Italy and Belgium stein
23:32 Q on retesting marne.platt

28 March, 2003
09:53 Re: Q on retesting Banie Boneschans
11:02 RE: Barcodes Italy and Belgium Lassoff, Peter
11:03 Toxicological Limits for Impurities. Srinivas Reddy

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