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AGG Food & Drug Newsletter - July 2021 | Arnall Golden Gregory LLP jdsupra.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from jdsupra.com Daily Mail and Mail on Sunday newspapers.
To embed, copy and paste the code into your website or blog: Arnall Golden Gregory LLP s Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from colleagues in other related life science disciplines. We are thinking of all of you in these difficult times, and hope that you and your loved ones are healthy and safe. Industry Insights Not a Very Happy Thanksgiving for One Pharmaceutical Company: OPDP Issues an Untitled Letter For Unlawful Promotion Instead of sending a turkey and cranberry sauce, in the spirit of 2020 where nothing is normal, the Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) made a different delivery this year for Thanksgiving. It sent an Untitled Letter to a pharmaceutical company for sending a misleading email to healthcare professionals about the prescription drug’s risks and ef ....
Overview On December 10th, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) announced significant proposed changes to the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The announcement continues a recent flurry of proposed rules at the end of the year and the term of the current administration. If finalized, the proposed rule would make numerous changes to the HIPAA Privacy Rule, including requiring a variety of operational changes from covered entities. While the proposed changes primarily impact covered entities, some of these changes may require operational changes by business associates and changes to business associate agreements, particularly on issues related to access. The proposed rule, however, does not make permanent the temporary flexibilities extended pursuant to the COVID-19 pandemic. ....