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Guidelines
Interim Final Rule with Request for Comments Released, Requiring More…
In mid-November 2021, several government agencies released a joint interim final rule with request for comments that requires…
FDA Revises COVID-19 ANDA Guidance
In early September 2021, the United States Food and Drug Administration (FDA) revised its Development of Abbreviated New Drug…
AdvaMed Releases Code of Ethics on Interactions with Health Care…
On October 1, 2021, the Advanced Medical Technology Association (AdvaMed) Code of Ethics on Interactions with health care…
FDA Updates Final Guidance on Biosimilar Development
Recently, the United States Food and Drug Administration (FDA) finalized additional questions and answers related to biosimilar…
FDA Finalizes Guidance on Field Alert Report Submissions
In late July 2021, the United States Food and Drug Administration (FDA) finalized guidance on expectations for field alert reports…
FDA Releases Draft Guidance on Sponsor Safety Reporting Requirements
Earlier this summer, the United States Food and Drug Administration (FDA) released updated draft guidance for sponsors on safety…
Interim Final Rule Released on Surprise Billing and Out-of-Network Charges
The Biden administration has released an interim final rule that bans surprise billing and certain out-of-network charges,…
HHS Releases Notice of Benefit and Payment Parameters for 2022, Part Two
Recently, the United States Department of Health and Human Services (HHS) released the Notice of Benefit and Payment Parameters…
Stark Law Final Rule Is Effective
Readers may remember that just one day before President Joe Biden was inaugurated as the 46th President of the United States, on…
FDA Releases Draft Guidance on IND Submissions for Individualized Antisense…
Earlier this year, the United States Food and Drug Administration (FDA) issued draft guidance surrounding investigational new drug…