May 6, 2021 – The outcome of a recent Advisory Committee meeting convened to review the uses of certain cancer drugs that were approved under the Food and Drug Administration’s (FDA’s) accelerated approval process sheds light on the potential pitfalls of the process after the approvals are granted. The FDA Oncologic Drugs Advisory Committee voted […]
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May 3, 2021 – Although the Food and Drug Administration (FDA) has issued more than 40 “Pre-Notices of Noncompliance” to companies to encourage voluntarily compliance with a federal requirement to submit all clinical trial data to the ClinicalTrials.gov database, last week the agency issued its first “Notice of Noncompliance” to Acceleron Pharma for not complying […]
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April 19, 2021 – Calling the basis for proposed medical device exemptions from premarket notification (510(k)) requirements “flawed,” the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) are withdrawing exemptions for 83 class II devices and one unclassified device which were proposed Jan. 15 in the last few days […]
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April 6, 2021 – The FDA’s Center for Drug Evaluation and Research (CDER) approved 14 new molecular entities (NMEs) in the first quarter—up from 11 in the same span in 2020. According to AgencyIQ, this is a record for any first quarter in FDA history. Taken together with the 53 NMEs approved in 2020 (story […]
Read more March 29, 2021 – The FDA does not issue certificates to medical device companies that register their facilities with the agency, nor does the registration of a device facility denote that products made in that facility are approved, cleared or authorized by the FDA, so a recent increase in the number of companies selling devices […]
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March 22, 2021 – The Department of Health and Human Services (HHS) has postponed for one year the effective date of its Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) final rule – put in place in the final days of the Trump administration – pending judicial review of a lawsuit filed March 9. In […]
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March 15, 2021 – The FDA Office of Prescription Drug Promotion (OPDP) marked the 10-year anniversary of the Bad Ad Program in 2020, and kicks off 2021 with three enforcement actions – two Warning Letters and one Untitled Letter – two of which cited the Bad Ad Program as the source of complaints about potentially […]
Read more Feb. 23, 2021 – Amid a surge in opioid overdose deaths over the past year – due in part to the ongoing COVID-19 pandemic and its corresponding isolation and lack of employment and support services – the FDA’s Office of Prescription Drug Promotion (OPDP) has asserted the agency’s “ongoing commitment to combat inappropriate opioid use.” […]
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Feb. 8, 2021 – With growing concern about the spread of new COVID-19 variants, companies developing vaccine modifications will not have to “start at square one,” according to Food and Drug Administration (FDA) Acting Commissioner Janet Woodcock, M.D.. Because of early indications that the initial vaccines may have lower effectiveness against one or more of […]
Read more Jan. 18, 2021 – Under the Biden administration, longtime Center for Drug Evaluation and Research (CDER) director and FDA veteran Janet Woodcock, M.D., has been tapped to serve as the acting commissioner of the Food and Drug Administration (FDA) after current FDA Commissioner Stephen Hahn, M.D., stepped down on Jan. 20. Media reports suggest that […]
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