02 January, 2004 |
| 11:18 |
Seasons Greetings |
A. D'Emanuele |
14 January, 2004 |
| 17:58 |
New Impurity in Drug Product in NME Formulation for Phase I Trials- Reg |
Satish Kumar Nachaegari |
| 18:27 |
Information on NME clinical trials- Regarding |
Satish Kumar Nachaegari |
| 18:27 |
Literature on registration of pharmaceutical products. |
Srinivas Reddy M |
| 18:27 |
Country of origin |
Dr Ankasha Tejam |
| 19:05 |
Combination Products |
Browne, Justin |
| 22:05 |
Re: Literature on registration of pharmaceutical products. |
Brian MATTHEWS |
| 22:05 |
Re: Combination Products |
Brian MATTHEWS |
15 January, 2004 |
| 09:26 |
RE: Combination Products |
Lassoff, Peter |
| 09:26 |
RE: Literature on registration of pharmaceutical products. |
Lassoff, Peter |
19 January, 2004 |
| 01:02 |
Testing requirements for packaging components |
Dan Sullivan |
| 06:11 |
RE: Testing requirements for packaging components |
MHA |
| 06:11 |
Re: Testing requirements for packaging components |
Brian MATTHEWS |
| 09:24 |
RE: Testing requirements for packaging components |
Lassoff, Peter |
| 10:18 |
Re: Testing requirements for packaging components |
Brian Matthews |
23 January, 2004 |
| 16:25 |
RE: New Impurity in Drug Product in NME Formulation for Phase I Trials- Reg |
Srinivas Reddy M |
03 February, 2004 |
| 16:11 |
ANDA requirements. |
Srinivas Reddy M |
09 February, 2004 |
| 19:00 |
Clinical Trials directive and EEA |
Frederic Ivanow |
11 February, 2004 |
| 17:39 |
Validation of pharacopoeial analytical methods |
Tomasz |
| 18:26 |
Re: Validation of pharacopoeial analytical methods |
Brian MATTHEWS |
| 18:55 |
Re: Validation of pharmacopoeial analytical methods |
Thomas Perrone |
12 February, 2004 |
| 10:25 |
RE: Validation of pharacopoeial analytical methods |
Tomasz ZawiÊlak |
15 February, 2004 |
| 07:02 |
SPL Standard |
b j |
21 February, 2004 |
| 15:51 |
Distribution of a Generic Product |
thirumurugant |
22 February, 2004 |
| 17:52 |
RE: Distribution of a Generic Product |
MHA |
23 February, 2004 |
| 21:29 |
RE: Distribution of a Generic Product |
Lassoff, Peter |
| 21:29 |
RE: Distribution of a Generic Product |
Post, Ivar |
| 23:37 |
RE: Distribution of a Generic Product |
stein |
24 February, 2004 |
| 11:16 |
Re: Distribution of a Generic Product |
HoroRL |
25 February, 2004 |
| 08:21 |
Purchasing Antibiotics |
Laura A. Halper |
07 March, 2004 |
| 19:20 |
Scored tablets |
stein |
| 19:30 |
RE: Scored tablets |
MHA |
08 March, 2004 |
| 08:04 |
Re: Scored tablets |
Brian MATTHEWS |
10 March, 2004 |
| 18:51 |
Re: Scored tablets |
stein |
| 18:51 |
RE: Scored tablets |
stein |
| 22:07 |
Re: Scored tablets |
Brian MATTHEWS |
11 March, 2004 |
| 08:06 |
Re: RE: Scored tablets |
rakesh kumar chaurasia |
| 09:45 |
RE: Scored tablets |
Lassoff, Peter |
12 March, 2004 |
| 10:27 |
21 CFR 660.21 |
Jane Smith |
| 11:47 |
RE: 21 CFR 660.21 |
Michelle O'Connor |
| 11:47 |
RE: Scored tablets |
Ivanow, Frederic [PRDGB] |
| 13:47 |
RE: 21 CFR 660.21 |
Terry Snape Consulting |
| 20:11 |
environmental monitoring for API synthesis |
Kristen Allen |
13 March, 2004 |
| 08:39 |
Re: environmental monitoring for API synthesis |
Bob Friedel |
| 08:39 |
21 CFR 660.21 contd |
Jane Smith |
| 08:39 |
Re: environmental monitoring for API synthesis |
rakesh kumar chaurasia |
| 14:01 |
RE: 21 CFR 660.21 |
MHA |
| 18:43 |
Re: environmental monitoring for API synthesis |
LewisMic |
14 March, 2004 |
| 22:30 |
RE: Scored tablets |
stein |
22 March, 2004 |
| 19:24 |
1989, 1991 and 1993 Editions of the FDA's Inactive Ingredient Guide |
Kitt Sinden |
| 22:25 |
RE: 1989, 1991 and 1993 Editions of the FDA's Inactive Ingredient Guide |
Marty Levy |
24 March, 2004 |
| 06:33 |
Decision Tree on when to waive in vivo bioequivalence studies |
Jonathan Attard |
01 April, 2004 |
| 21:43 |
Question regarding the QP for Clinical Trials |
Ifty Saiyed |
08 April, 2004 |
| 12:29 |
RE: Question regarding the QP for Clinical Trials |
Post, Ivar |
28 April, 2004 |
| 13:30 |
Discussion forums for world wide Patent related and Clinicaltrial related queries? |
Dr Ankasha Tejam |
17 May, 2004 |
| 12:03 |
Hybrid applications |
Mona Gogia |
| 16:21 |
Re: Hybrid applications |
Brian Matthews |
18 May, 2004 |
| 13:25 |
Use two vendor for API |
Chintan Patel |
| 13:25 |
Parenteral products application |
Chintan Patel |
| 20:24 |
RMS questions & updates of CTD |
Tony |
| 20:27 |
Re: Use two vendor for API |
Brian Matthews |
| 20:53 |
Re: Use two vendor for API |
Michael Anisfeld |
| 21:31 |
Re: RMS questions & updates of CTD |
Brian MATTHEWS |
19 May, 2004 |
| 09:13 |
Subject: RMS questions & updates of CTD |
Nicola Nestor |
21 May, 2004 |
| 08:45 |
FDC Bioequivalence study |
Chintan Patel |
| 09:24 |
ANDA application |
Sabita Nair |
| 10:24 |
Re: ANDA application |
Brian MATTHEWS |
| 10:46 |
Re: ANDA application |
mona.gogia |
| 10:46 |
RE: ANDA application |
Regulatory |
| 11:04 |
RE: ANDA application |
mona.gogia |
| 12:04 |
Process validation of Lyophilized product |
Chintan Patel |
| 18:15 |
RE: Process validation of Lyophilized product |
Bales, Frank |
22 May, 2004 |
| 11:22 |
21 CFR 314.420 (d) |
L. Hansa |
| 16:21 |
Piggyback Licence |
Chintan Patel |
| 16:21 |
RE: 21 CFR 314.420 (d) |
MHA |
| 20:13 |
Re: Piggyback Licence |
Brian MATTHEWS |
25 May, 2004 |
| 09:22 |
leak test |
Sinha Abhishek |
28 May, 2004 |
| 13:56 |
Advice on MRP |
Vincent Wek |
| 14:32 |
Re: Advice on MRP |
Brian MATTHEWS |
31 May, 2004 |
| 08:26 |
Specific MA dossiers in the EU |
Sabita Nair |
01 June, 2004 |
| 10:49 |
Specific MA dossiers in the EU |
NNestor |
03 June, 2004 |
| 11:56 |
Non-clinical and clinical summary |
Sabita Nair |
04 June, 2004 |
| 17:43 |
Re: RegAffairs Digest - 04/06/04 |
NNestor |
12 June, 2004 |
| 18:13 |
Batch Size Requirements for Parenterals - Grand Father Clause - ANDA submission. |
Srinivas Reddy M |
15 June, 2004 |
| 08:02 |
Packaging information in an ANDA |
Sabita Nair |
26 June, 2004 |
| 11:53 |
Change in API Vender |
Regulatory |
| 13:18 |
Re: Change in API Vender |
bruce berger |
29 June, 2004 |
| 05:18 |
MSc in Regulatory Affairs |
Nicola Nestor |
| 08:53 |
Re: MSc in Regulatory Affairs |
lt09 |
| 10:38 |
RE: MSc in Regulatory Affairs |
Lassoff, Peter |
| 10:59 |
Re: MSc in Regulatory Affairs |
vardhini |
| 13:30 |
RE: MSc in Regulatory Affairs |
Bob Friedel |
| 14:36 |
RE: MSc in Regulatory Affairs |
Peter Geffen |
| 14:36 |
RE: MSc in Regulatory Affairs |
lt09 |
30 June, 2004 |
| 16:06 |
RE: MSc in Regulatory Affairs |
Lassoff, Peter |
13 July, 2004 |
| 10:59 |
Topical Products |
thirumurugan gopalasamy |
14 July, 2004 |
| 15:48 |
TSE risk assessment for clinical trial materials for Europe |
cheryl.elkins |
| 16:45 |
Compassionate Use in Canada |
rmaclean |
| 17:00 |
Re: Compassionate Use in Canada |
Ian MacKay |
21 July, 2004 |
| 12:45 |
Examples of different national requirements |
Despina Samara |
