01 January, 2006 |
| 17:00 |
Re: ISO vs GMP |
Jay2rees |
02 January, 2006 |
| 10:46 |
New EU legal framework for harmonisation of the data exclusivity |
Zdravko Mauko, FARMAVITA |
| 11:18 |
Seasons Greetings |
A. D'Emanuele |
| 14:38 |
time frame for DMF |
Ashish |
| 14:47 |
Licensing and DMF |
Ashish |
03 January, 2006 |
| 11:14 |
time frame for DMF |
Zdravko Mauko, FARMAVITA |
| 13:40 |
Re: time frame for DMF |
Ashish Mohan |
| 19:45 |
Assistance with obtaining journal articles that appeared over 10 years ago |
Michael Anisfeld |
04 January, 2006 |
| 11:07 |
Re: Assistance with obtaining journal articles that appeared over 10 years ago |
bruce berger |
| 22:37 |
Re: Assistance with obtaining journal articles that appeared over 10 years ago |
Stanley110 |
05 January, 2006 |
| 13:45 |
Re: BE Injectables |
Marcio.O.Silva |
09 January, 2006 |
| 18:00 |
Authorized Generic |
Naren |
11 January, 2006 |
| 10:04 |
Biowaiver in Canada |
Nisha K R |
| 11:04 |
Re: Biowaiver in Canada |
gitarao |
25 January, 2006 |
| 09:39 |
Data Exclusivity |
Ashish |
26 January, 2006 |
| 10:40 |
RE: Data Exclusivity |
Zdravko Mauko |
| 11:36 |
8+2+1 Data Exclusivity in EU |
Zdravko Mauko, FARMAVITA |
27 January, 2006 |
| 19:09 |
Re: Data Exclusivity |
Ashish NIPER |
| 20:17 |
RE: Data Exclusivity |
Steve Binysh |
28 January, 2006 |
| 12:26 |
Data Exclusivity in USA |
Zdravko Mauko, FARMAVITA |
| 17:06 |
DMF holder can ? |
Ashish NIPER |
29 January, 2006 |
| 16:58 |
RE: DMF holder can ? |
Steve Binysh |
| 21:28 |
RE: DMF holder can ? |
Lassoff, Peter |
30 January, 2006 |
| 08:15 |
Injectable Grade Regulatory Requirements |
durgabp |
| 10:20 |
RE: DMF holder can ? |
Michael Anisfeld |
| 10:31 |
Re: Injectable Grade Regulatory Requirements |
lt09 |
| 10:31 |
RE: Injectable Grade Regulatory Requirements |
Michael Anisfeld |
| 21:51 |
RE: DMF holder can ? |
Steve Binysh |
31 January, 2006 |
| 17:37 |
API GMPs: ICH-Q7A |
Michael Anisfeld |
| 23:18 |
EU identification of packages |
stein |
01 February, 2006 |
| 07:58 |
RE: API GMPs: ICH-Q7A |
Peter Geffen |
| 10:14 |
rapid microbiology method for sterility testing |
Nimrod |
| 14:45 |
Generic applications via Centralised Procedure |
Vincent Kuanyin Agoth Wek |
| 17:04 |
RE: API GMPs: ICH-Q7A |
Michael Anisfeld |
| 20:40 |
Re: Generic applications via Centralised Procedure |
lt09 |
| 21:47 |
RE: DMF holder can ? |
Lassoff, Peter |
02 February, 2006 |
| 09:17 |
re API GMPs: ICH-Q7A - Audit of Suppliers |
Andrew Downing |
| 20:40 |
RE: Generic applications via Centralised Procedure |
Steve Binysh |
03 February, 2006 |
| 07:13 |
RE: Generic applications via Centralised Procedure |
Lassoff, Peter |
| 07:52 |
Re: Generic applications via Centralised Procedure |
arvinda |
| 19:10 |
RE: API GMPs: ICH-Q7A |
Lassoff, Peter |
04 February, 2006 |
| 16:58 |
RE: API GMPs: ICH-Q7A |
lt09 |
05 February, 2006 |
| 20:39 |
RE: API GMPs: ICH-Q7A |
Lassoff, Peter |
06 February, 2006 |
| 15:39 |
Re: API GMP audit--Michael Ansfield Question |
alanlongworth |
07 February, 2006 |
| 08:40 |
RE: API GMPs: ICH-Q7A |
lt09 |
| 22:00 |
RE: API GMPs: ICH-Q7A |
Michael Anisfeld |
13 February, 2006 |
| 14:49 |
Import of drugs to India |
Jayram ramesh |
15 February, 2006 |
| 07:58 |
Solution,Syrups and Suspension |
yash wardhan |
| 07:58 |
BA/BE across regulated markets |
Nisha K R |
17 February, 2006 |
| 09:09 |
CTD Module 1 |
Shalaka Mishra |
| 18:56 |
RE: CTD Module 1 |
Tim Felgate |
| 18:57 |
Re: CTD Module 1 |
lt09 |
| 19:44 |
impurities in drug product. |
A. D'Emanuele |
18 February, 2006 |
| 13:46 |
RE: impurities in drug product. |
Steve Binysh |
20 February, 2006 |
| 07:40 |
Regulatory Publications |
Nisha K R |
| 08:58 |
RE: Regulatory Publications |
Tim Felgate |
21 February, 2006 |
| 15:03 |
Gamma Irradiation of API |
Michael Anisfeld |
| 22:12 |
OTC Monograph |
thirumurugan gopalasamy |
22 February, 2006 |
| 08:08 |
Re: OTC Monograph |
arvinda |
| 08:10 |
API - Date of Manufacture |
Michael Anisfeld |
| 09:27 |
Re: API - Date of Manufacture |
Theodor Poettinger |
| 21:47 |
Stability data 505(b)(2) NDA |
Michael Beckert |
24 February, 2006 |
| 12:28 |
Change of Servers this weekend |
PharmWeb-Admin |
02 March, 2006 |
| 14:36 |
RE: Sunscreen Products |
David |
| 14:37 |
RE: API - Date of Manufacture |
snair |
| 14:43 |
RE: API - Date of Manufacture |
snair |
| 14:48 |
RE: API - Date of Manufacture |
Theodor Poettinger |
| 16:38 |
Sunscreen Products |
Michael Anisfeld |
| 16:40 |
RE: API - Date of Manufacture |
Theodor Poettinger |
| 17:08 |
RE: Sunscreen Products |
Lassoff, Peter |
| 19:49 |
RE: Sunscreen Products |
Lassoff, Peter |
03 March, 2006 |
| 06:40 |
Test methods of Inactive ingredients in ANDA |
Nisha K R |
| 06:41 |
FDA inspection of foreign OTC manufacturing facilities |
Bahirathan Mahesan |
| 09:06 |
RE: API - Date of Manufacture |
snair |
| 09:07 |
Re: API - Date of Manufacture |
Brian MATTHEWS |
| 09:21 |
Re: FDA inspection of foreign OTC manufacturing facilities |
bruce berger |
| 09:21 |
Re: Test methods of Inactive ingredients in ANDA |
bruce berger |
| 11:57 |
RE: API - Date of Manufacture |
Michael Anisfeld |
| 12:11 |
RE: Sunscreen Products |
Michael Anisfeld |
| 13:31 |
RE: Sunscreen Products |
bruce berger |
| 15:12 |
RE: Sunscreen Products |
Michael Anisfeld |
11 March, 2006 |
| 08:51 |
Process Validation |
thirumurugan gopalasamy |
14 March, 2006 |
| 09:19 |
Re: Impurity Qualification |
arvinda |
| 18:21 |
Bioeq CRO Inspection - Brazilian Legislation |
Marcio.O.Silva |
| 23:03 |
Re: Bioeq CRO Inspection - Brazilian Legislation |
Marcio.O.Silva |
18 March, 2006 |
| 08:33 |
Batch Definitions |
Michael Anisfeld |
19 March, 2006 |
| 18:49 |
RE: Batch Definitions |
Steve Binysh |
21 March, 2006 |
| 20:09 |
API expiry question |
Eden Venti |
| 23:09 |
RE: Batch Definitions |
Steve Binysh |
22 March, 2006 |
| 07:33 |
Re: API expiry question |
kuntal chatterjee |
| 07:35 |
Re: API expiry question |
Nisha K R |
| 09:56 |
Re: API expiry question |
Brian MATTHEWS |
23 March, 2006 |
| 06:13 |
Re: API expiry question |
Nisha K R |
| 08:05 |
Re: API expiry question |
Brian MATTHEWS |
| 21:44 |
RE: API expiry question |
Lassoff, Peter |
29 March, 2006 |
| 14:36 |
ANDA Package insert related query |
vardhini kirthivas |
| 17:57 |
RE: ANDA Package insert related query |
Peter Rais |
30 March, 2006 |
| 09:07 |
Re: ANDA Package insert related query |
bruce berger |
| 10:17 |
RE: ANDA Package insert related query |
kalpana m dhumal |
05 April, 2006 |
| 22:14 |
FDA Stability Guideline |
Marcio.O.Silva |
