The FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” By Holly N. Brevig, Senior Regulatory Device and Biologics Exper & Richard A.

FDA 105

FDA Documentation 105

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

Documentation 52

Documentation FDA Labelling 52

ISPE

SEPTEMBER 15, 2022

First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. Thomas Zimmer, PhD. 15 September 2022. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. 12 of February 2020 again received 2,000 comments from public consultation.

Documentation 97

Documentation FDA 97

The Checkup by Singlecare

APRIL 17, 2024

Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them. According to Dr. Bonza, these requirements might include a documented diagnosis of Type 2 diabetes mellitus and confirmation with a medical test.

Insurance 98

Insurance Insurance Coverage Compounding Pharmacies Compounding 98

pharmaphorum

JANUARY 4, 2022

Stanford University drop-out Holmes founded Theranos in 2003 when she was just 19, and at its height the company was worth $9 billion, with its founder feted as the next Steve Jobs. She admitted using pharma company logos – including Pfizer – on Theranos documents sent to investors, even though they had not endorsed the technology.

Documentation 52

Documentation Communication FDA 52

ISPE

MAY 9, 2023

Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

NOVEMBER 2, 2022

ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.

Documentation 52

Documentation Compounding Communication FDA 52