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RSS FeedPosted by Michael Wonder on 16 Aug 2022
EMA publishes agenda for 16-19 August CHMP meeting
16 August 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 21 Jul 2022
FDA offers new guidance on therapeutic equivalence evaluations
20 July 2022 - In draft guidance issued on Wednesday, the US FDA explains its approach to therapeutic equivalence evaluations and ...
Posted by Michael Wonder on 19 Jul 2022
EMA publishes agenda for 18-21 July 2022 CHMP meeting
18 July 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 07 Jul 2022
EMA finalises companion diagnostic guidance
7 July 2022 - The EMA) has finalised guidance on companion diagnostics, addressing procedural aspects to facilitate consultation between EMA ...
Posted by Michael Wonder on 20 Jun 2022
EMA publishes agenda for 20-23 June 2022 CHMP meeting
20 June 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 24 May 2022
EMA guidance supports development of new antibiotics
24 May 2022 - As part of its efforts to support a global approach to the development of new antimicrobial medicines, ...
Posted by Michael Wonder on 16 May 2022
EMA publishes agenda for 16-19 May 2022 CHMP meeting
16 May 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 19 Apr 2022
EMA publishes agenda for 19-22 April 2022 CHMP meeting
19 April 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 17 Mar 2022
COVID-19 vaccine weekly safety report (17 March 2022)
17 March 2022 - To 13 March 2022, the TGA has received 457 reports which have been assessed as likely to ...
Posted by Michael Wonder on 16 Mar 2022
FDA drafts guidance on genome editing, CAR T cell therapies
16 March 2022 - The U.S. FDA has issued two draft guidances addressing the development of human gene therapy products that ...
Posted by Michael Wonder on 15 Feb 2022
Office of Generic Drugs 2021 Annual Report
14 February 2022 - Ensuring high quality, affordable generic drugs are available to the American public. ...
Posted by Michael Wonder on 27 Jan 2022
FDA enforces ClinicalTrials.gov results posting requirements, including threats of financial penalty
27 January 2022 - Clinical trials requiring registration on ClinicalTrials.gov generally must have results submitted no later than one year after ...
Posted by Michael Wonder on 24 Jan 2022
EMA publishes agenda for 24-27 Jan CHMP meeting
23 January 2022 - The EMA has published a draft agenda for this week's CHMP meeting. ...
Posted by Michael Wonder on 22 Jan 2022
COVID-19 vaccines and treatments: we must have raw data, now
19 January 2022 - Data should be fully and immediately available for public scrutiny ...
Posted by Michael Wonder on 14 Jan 2022
Advancing health through innovation: new drug therapy approvals 2021
13 January 2022 - The FDA’s Center for Drug Evaluation and Research has issued its report, Advancing Health Through Innovation: New ...