July 12, 2021 – The COVID-19 pandemic did not slow down the drug approval process for the FDA’s Center for Drug Evaluation and Research (CDER) in 2020 – a year that saw CDER approve the second-highest number of new molecular entities (NMEs) – and that pace seems to be holding steady in 2021, with CDER […]
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June 11, 2021 – The Food and Drug Administration (FDA) “is really central, not only to product approvals, but to what [medical product companies] can say in terms of marketing,” according to Prevision Policy Senior Editor Kate Rawson. Rawson, who spoke June 4 at a Coalition for Healthcare Communication (CHC) webinar, “What’s Ahead for the […]
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June 7, 2021 — Despite ongoing speculation about who will be the next Commissioner of the Food and Drug Administration (FDA), “the real leadership story is at CDER,” the Center for Drug Evaluation and Research, according to Kate Rawson, senior editor of Prevision Policy. As Rawson explained during a June 4 webinar on “What’s Ahead […]
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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 […]
Read more 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 […]
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