FDA Policy/General

Bharwani Promoted to FDA Global Policy and Strategy Deputy

FDA’s Office of Global Policy and Strategy principal advisor Ravi Bharwani has been promoted to OGPS deputy director. Since 2021, he served as principal policy advisor in OGPS’ immediate office (IO) leading stakeholder or counterpart engagements and coordination, advising the associate commissioner on complex issues, and managing IO functions, according to his bio.

Bharwani has been at FDA since 2007. “Upon graduating from American University with a degree in public policy, he was selected as the first employee to join the new ORA Quality Management Staff,” the bio says. In 2013, he joined the newly formed Office of Public Health and Trade in what was then the Office of International Programs as an international trade policy analyst. He joined the Global Regulatory Operations and Policy Directorate (GO) in 2017 as a policy advisor where he negotiated FDA equities in the United States-Mexico Canada Agreement, and coordinated policy issues with HHS and trade-promoting agencies.

2 Charged in Counterfeit Ozempic Scheme

The U.S. Attorney’s Office for the Middle District of Florida and the Department of Justice’s Criminal Division have announced federal charges against Swapnadip Roy and Vicky Ramancha. The two Indian nationals have been charged with conspiracy and smuggling related to an alleged transnational counterfeit prescription drug distribution

Warning Letters Instructive on Documentation

Five FDA drug company 2026 Warning Letters should be studied by other manufacturers who want to learn more about the agency’s position on documentation defensibility, according to a Quality Digest online post. The post says that in each of the five letters, that were issued within seven weeks, a

Fresenius Kabi USA CGMP Violations

A 1/27-2/18 FDA inspection at the Fresenius Kabi USA drug manufacturing facility in Melrose Park, IL, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 9/22 Warning Letter says the three specific violations were: * failure to thoroughly investigate any unexplained discrepancy

Democratic Women in Congress Want Action on Estradiol Patch Shortage

Some 44 members of the congressional Democratic Women’s Caucus have written to FDA acting commissioner Kyle Diamantas and HHS secretary Robert F. Kennedy Jr., asking that they immediately address the ongoing shortage of estradiol transdermal patches that help manage menopause symptoms. A caucus statement (contains a link to the

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2 Charged in Counterfeit Ozempic Scheme

Warning Letters Instructive on Documentation

Fresenius Kabi USA CGMP Violations

Democratic Women in Congress Want Action on Estradiol Patch Shortage