Blog
RSS FeedPosted by Michael Wonder on 13 Oct 2023
2024 Medicare Parts A & B premiums and deductibles
12 October 2023 - Today, the CMS released the 2024 premiums, deductibles, and coinsurance amounts for the Medicare Part A ...
Posted by Michael Wonder on 01 Feb 2023
Changes applying to evaluation of new substances for listed medicines
1 February 2023 - The TGA has introduced Mandatory requirements for applications to vary the Permissible Ingredients Determination under section 26BD ...
Posted by Michael Wonder on 07 Dec 2022
An innovation surcharge to fund the repurposing of generic drugs
10 November 2022 - The use of generic drugs continues to increase, generating substantial savings for purchasers and improving affordable access ...
Posted by Michael Wonder on 15 Sep 2022
FDA’s drug industry fees fuel concerns over influence
15 September 2022 - The pharmaceutical industry finances about 75% of the agency’s drug division, through a controversial program that ...
Posted by Michael Wonder on 28 Jun 2022
Fees and charges: summary from 1 July 2022
27 June 2022 - The TGA has updated its summary of fees and charges effective 1 July 2022. ...
Posted by Michael Wonder on 23 Jun 2021
Fees and charges: summary from 1 July 2021
23 June 2021 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 23 Mar 2021
Indian cancer drug manufacturer to pay $50 million for concealing and destroying records in advance of FDA inspection
23 March 2021 - Indian drug manufacturer Fresenius Kabi Oncology was sentenced to pay $50 million in fines and forfeiture ...
Posted by Michael Wonder on 15 Feb 2021
Pay for plasma collection coming to Alberta by end of the year
14 February 2021 - Repeal of NDP bill last fall clears way for Canadian Plasma Resources to set up shop. ...
Posted by Michael Wonder on 03 Feb 2021
Cost recovery implementation statement (2020-2021)
3 February 2021 - This Cost Recovery Implementation Statement provides information on how the Therapeutic Goods Administration, within the Department of ...
Posted by Michael Wonder on 02 Jul 2020
Reduced annual charges for medical devices listed on the prostheses list
2 July 2020 - In response to the suspension of elective surgery due to COVID-19 and the significant impact this has ...
Posted by Michael Wonder on 23 Jun 2020
Academia developing medicines for rare diseases to receive free EMA scientific advice
23 June 2020 - To further encourage the development of treatments for rare diseases, EMA will waive all fees for ...
Posted by Michael Wonder on 23 Jun 2020
Submissions received: fees and charges proposal 2020-21
23 June 2020 - On 20 January 2020, the Therapeutic Goods Administration (TGA) released on its website a consultation paper, ...
Posted by Michael Wonder on 18 Jun 2020
Fees and charges: summary from 1 July 2020
18 June 2020 - The TGA is required to recover its costs for all activities that fall within the scope of ...
Posted by Michael Wonder on 04 Jun 2020
FDA re-evaluates user fees for biosimilar reviews
4 June 2020 - Even before the pandemic, the FDA was having trouble estimating its resource needs for biosimilar application reviews. ...
Posted by Michael Wonder on 16 Apr 2020
COVID-19 update: FDA continues user-fee related reviews
16 April 2020 - The U.S. FDA's User Fee programs help us fulfil our mission to protect public health while ...