- September 2019: 34 new and 19 revised product-specific FDA BE guidelines nobody 2019-09-24 10:58
- BE in hepatic impairment? nobody 2019-08-30 09:29
- ICH E8(R1) step 2b Helmut 2019-06-03 10:02
- ICH E8(R1) step 2b ElMaestro 2019-06-03 23:18
- ICH E8(R1) step 2b Ohlbe 2019-06-04 04:03
- ICH E8(R1) step 2b ElMaestro 2019-06-03 23:18
- FDA Web page Rosy 2019-05-03 16:28
- Redesign of the FDA’s site: A rant ☠ Helmut 2019-05-03 17:28
- WHO Questions and Answers: similar biotherapeutic products Helmut 2019-04-15 00:25
- Pharmacokinetic Solidarity? mittyri 2019-04-02 12:32
- Pharmacokinetic Solidarity? nobody 2019-04-02 12:39
- Pharmacokinetic Solidarity? Helmut 2019-04-02 13:00
- Pharmacokinetic Solidarity? nobody 2019-04-02 13:37
- Pharmacokinetic Solidarity? Helmut 2019-04-02 13:00
- Pharmacokinetic Solidarity? nobody 2019-04-02 12:39
- News from EMA: Pharmacokinetic Solidarity EMA.Press.Office 2019-04-01 00:07
- Good bye! Fare well, Canary Wharf! And nevermore. Helmut 2019-03-11 23:40
- Good bye! Fare well, Canary Wharf! And nevermore. jag009 2019-03-12 03:14
- Brexit Helmut 2019-03-12 09:57
- Good bye! Fare well, Canary Wharf! And nevermore. jag009 2019-03-12 03:14
- Outliers: The FDA follows the EMA Helmut 2019-03-05 01:24
- Outliers: The FDA follows the EMA jag009 2019-03-06 19:23
- All animals are equal, but some animals are more equal than others Helmut 2018-10-09 14:33
- Redesign of the EMA’s website Helmut 2018-10-08 12:20
- FDA: Dissolution Testing and Acceptance Criteria for IR… Helmut 2018-09-03 14:46
- FDA: ANDA Submissions—Amendments to ANDAs Under GDFUA Helmut 2018-08-09 10:52
- ICH M9 Draft Helmut 2018-07-16 14:49
- EMA: 2 product-specific guidances adopted Helmut 2018-06-26 14:40
- EMA: New product-specific draft guidances published mmw 2018-06-29 07:20
- EMA: New product-specific draft guidance published Helmut 2018-07-05 15:11
- EMA: 5 product-specific guidances adopted Helmut 2018-08-03 16:52
- EMA: New product-specific draft guidances published mmw 2018-06-29 07:20