• This Week at FDAThis Week at FDA

    This Week at FDA: Califf and Pazdur on return to office, accelerated approval, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we heard from FDA Commissioner Robert Califf and Oncology Center of Excellence (OCE) Director Richard Pazdur about FDA’s return to office plans, accelerated approvals and a new initiative called Project Pragmatica.   FDA’s Cardiovascular and Renal Drugs Advisory Committee ...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Califf on Twitter, ‘face-to-face’ meetings, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. To kick off the week, FDA Commissioner Robert Califf tweeted that he and FDA will remain active on Twitter following Tesla CEO Elon Musk’s takeover of the company and concerns about a laxer approach to moderation under Twitter’s new ownership. We also noted FDA’s updated definition of “f...
  • This Week at FDAThis Week at FDA

    This Week at FDA: User fee reauthorization, Amylyx ALS drug approved, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. Just hours ago, the House voted 230-201 to approve a stopgap funding bill that will reauthorize FDA’s user fee programs for the next five years.   The news comes as a relief to FDA and the medical product manufacturers who spent months negotiating the user fee deals. The user fee p...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Hope for user fee reauthorization, EMA says COVID-19 pandemic not over yet

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest development of the week is news that Congress actually may pass a user fee reauthorization bill. Regulators also have published several major guidances this week including one on electronic submission of 510(k) applications.   While the US Food and Drug Administration has...
  • This Week at FDAThis Week at FDA

    This Week at FDA: A ‘reasonable expectation’ for user fee reauthorization

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. With Congress back in session and the end of the fiscal year rapidly approaching, attention once again turns to user fee reauthorization and appropriations.   Both Politico and BioCentury reported this week that an FDA spokesperson said the agency has a “reasonable expectatio...
  • This Week at FDAThis Week at FDA

    This Week at FDA: ACIP signs off on bivalent boosters

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to authorize bivalent COVID-19 vaccine boosters from Pfizer-BioNTech and Moderna. On Thursday, a key Centers for Disease Control and Prevention (CDC) panel voted 13-1 in support of both modified boosters.   On Wednesday,...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Califf confirms no VRBPAC for bivalent boosters

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that both Pfizer and Moderna are seeking FDA authorization for their bivalent COVID-19 vaccines containing components of both the prototype virus and Omicron BA.4/5. FDA’s decision to authorize the updated boosters could come as early as next week, and FDA Commissio...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Amazon warning letter, ANDA amendments, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we take a look at warning letters sent to online retail giant Amazon and two other companies for selling unapproved drugs for mole and skin tag removal. Plus, FDA has opened a public docket to gather feedback on its abbreviated new drug application (ANDA) amendments guidance, ...
  • Regulatory NewsRegulatory NewsThis Week at FDAThis Week at FDA

    This Week at FDA: EtO, user fee woes, and product specific guidances

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week the Environmental Protection Agency (EPA) said it would publish a new rule by year’s end that could have serious consequences for the ethylene oxide (EtO) sterilizers and the medtech industry; the head of the US Food and Drug Administration (FDA) tried to assure staff he’s doing...
  • This Week at FDAThis Week at FDA

    This Week at FDA: Remote regulatory assessments guidance, 12-digit NDCs, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation and what we’re reading from around the web. This week, FDA released its long-awaited guidance on how it plans to incorporate remote regulatory assessments across product areas going forward. The agency also issued a proposed rule to adopt a uniform 12-digit format for national drug codes (NDCs) and updated its list of medical devic...
  • This Week at FDAThis Week at FDA

    This Week at FDA: USPTO, FDA align on drug competition, Paxlovid from your pharmacist, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week, we learned that FDA is looking to hire a media-savvy physician to direct its communication strategy. The agency also authorized state-licensed physicians to prescribe Pfizer’s COVID-19 antiviral drug. Plus, we read that FDA and the US Patent and Trademark Office (USPTO) are pl...
  • This Week at FDAThis Week at FDA

    This Week at FDA: User fee timeline, bivalent boosters, and more

    Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. The biggest news out of FDA this week was the agency’s decision to recommend the inclusion of an Omicron BA.4/5 component in future booster doses in the first shift in strain composition away from monovalent vaccines targeting the prototype virus.   Alongside the recommendation, FD...