Jacqueline Berman
@berman_jackie1
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FDA regulatory Partner @MorganLewisLaw. Tweets represent my views only.
Joined May 2018
FDA expertise and decision-making on drug safety and efficacy are under judicial attack! Read article below.
morganlewis.com
While the US Court of Appeals for the Fifth Circuit has temporarily stayed the Texas district court’s ruling invalidating the US Food and Drug Administration’s (FDA’s) approval of mifepristone, the...
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Get your daily dose of information on what's going on in the Pharma and Biotech sectors. https://t.co/5YjleXuktR
#FDA #biotechnews #pharmanews
morganlewis.com
While many provisions of the FY 2023 Consolidated Appropriations Act (Omnibus) have received much attention, one has flown under the radar. In its explanatory statement on the Omnibus, the US...
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CMS announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway. Check out the blog below. https://t.co/pNqYalLaE4
morganlewis.com
The Centers for Medicaid and Medicare Services (CMS) announced a model on February 14, 2023 that would allow CMS to pay less for drugs approved via FDA’s accelerated approval pathway before a...
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Absent a legislative fix or further court action, there still remains uncertainty regarding the exact scope of orphan drug exclusivity periods. Check out the article below. https://t.co/qlqNYyk3Ur
morganlewis.com
Partner Jacqueline Berman wrote a Law360 Expert Analysis article on how a new US Food and Drug Administration notice—which contrasts with an Eleventh Circuit ruling on orphan drug exclusivity—makes...
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Excited to be attending the MassBio State of Possible conference. If you are here, come and say hi!
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Partner Jacqueline Berman sits down with Peter Marks, Director of the FDA's Center for Biologics Evaluation and Research during @BioNJ_Org's C-Suite Summit on 10/15 to share perspectives on emerging trends from the pandemic and the future of innovation: https://t.co/enc4p8HywK
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Very proud to be working for a firm committed to our civic duties. Go Vote!
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FDA updates its guidance on certain DSCSA enforcement policies-Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements
fda.gov
Guidance for Industry - Procedural
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How close is too close? Check out this important update from my colleagues--CDC Expands Definition of ‘Close Contact’ to Include Multiple Short Interactions
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Looking forward to seeing everyone today for a great discussion! FDLI Annual Conference: Exploring Advanced Topics in Food and Drug Law
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FDA is resuming domestic inspections next week. Read all about it! FDA Adapts to the New Normal: Domestic Inspections Resuming Based on Tiered Risk Assessments
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Check out our summary of all of FDA's drug and biologic guidances to date. As FDA begins to look forward to the new normal, more is likely to come! FDA COVID-19 Guidance Roundup for Drug and Biologics
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Lots of guidance coming out of FDA on a daily basis. FDA updates guidance on certain delayed AE reporting during the pandemic. #mllifesci #wearemorganlewis #ML_AsPrescribed FDA Issues Guidance on Postmarket Adverse Event Reporting During Pandemics
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Great summary of the CARES Act for drug, device, and food manufacturers/suppliers authored by the ML FDA group #mllifesci #wearemorganlewis #ML_AsPrescribed CARES Act Provisions Impact Drug, Device, and Food Manufacturers and Suppliers
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Additional steps by FDA to facilitate access to hand sanitizer. #mllifesci #wearemorganlewis #ML_AsPrescribed FDA Issues New Temporary Policy for the Manufacture of Alcohol for Hand Sanitizer Products
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Widely expected to pass both houses of the US Congress by March 27, and to be signed into law by the president, the #CARESAct lays out a $2 trillion economic stimulus. We provide a high-level summary of key portions of the bill: https://t.co/TZqRpsPC1q
#COVID19 #coronavirus
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FDA takes steps to facilitate patient access to REMS drugs. Read all about it. #mllifesci #wearemorganlewis #ML_AsPrescribed COVID-19: FDA Permits Healthcare Providers to Forgo Certain Risk Evaluation, Mitigation Strategies
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