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Nov 4, 2024 | 
thefdalawblog.com | Karla Palmer |John W.M. Claud |Sara W. Koblitz
As we reported back in January, Phibro Animal Health Corporation challenged FDA’s decision to remove a drug called carbadox—used as an antimicrobial drug to treat gastrointestinal disease in food-producing pigs—from the market. More specifically, FDA rescinded approval of a “regulatory method” that Phibro used to establish that carbadox is safe and effective.
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Nov 3, 2024 | 
thefdalawblog.com | Sara W. Koblitz |JP Ellison |John W.M. Claud
Back in July, the United States Supreme Court turned the world of administrative law on its head, adding new layers of judicial oversight to what might have previously been thought of as fairly non-descript Federal agency functions. One of those cases was Loper Bright v. Raimondo, which formally overruled the 40-year precedent under Chevron, under which courts gave agencies deference when interpreting statutory ambiguity.
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Oct 28, 2024 | 
thefdalawblog.com | John W.M. Claud |Deborah Livornese
On October 21, 2024, the Alliance for Natural Health USA (“ANH”), and Meditrend Inc., a homeopathic drug company, filed a complaint on behalf of the homeopathic drug industry against FDA in the District Court for the District of Columbia (“D.D.C.”). This lawsuit presents an interesting reading of the statute at issue, one that is diametrically opposed to that of FDA. The genesis of this lawsuit is a disagreement over regulatory language and, more significantly perhaps, statutory interpretation.
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Sep 11, 2024 | 
thefdalawblog.com | John W.M. Claud
Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. Nitrosamines are impurities that can form during drug manufacturing and are considered potentially . One specific kind of nitrosamines called N-nitrosamine drug substance-related impurities, or NDSRIs, are especially vexing to FDA and to industry because they mimic the structure of the specific active pharmaceutical ingredients (API), making them difficult to detect.
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Aug 15, 2024 | 
bioprocessonline.com | John W.M. Claud |Ryan Martin
AI and machine learning are the buzzwords of the decade, often accompanied by lofty promises — but what do they really mean for biopharma? How can these technologies be adopted to improve biomanufacturing processes, testing, and quality? Join Bioprocess Online Live for an exploration into the practical applications of AI/ML in biomanufacturing, its barriers to adoption, and how regulators can help standardize use across the industry. Registration is free thanks to the support of Atum Bio.
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Aug 10, 2024 | 
pharmaceuticalonline.com | Tim Sandle |John W.M. Claud |Mark Witcher |Geraldine Carr-Mulry
JULY'S BEST FEATURED EDITORIALChatGPT-4: Practical Applications For The Biopharma LaboratoryAI has made its way into the biopharma laboratory, and ChatGPT-4 is the most popular. Do you know the capabilities that this tech can deliver? Making Good Decisions When FDA Investigators Come KnockingReady or not, when the FDA inspector arrives, the test has already started. New final guidance makes clear what the agency considers an attempt to stonewall.
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Jul 31, 2024 | 
bioprocessonline.com | John W.M. Claud
By John W.M. Claud, counsel, Hyman, Phelps & McNamara
There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy.
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Jul 31, 2024 | 
outsourcedpharma.com | John W.M. Claud |Louis Garguilo
By John W.M. Claud, counsel, Hyman, Phelps & McNamara
There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy.
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Jul 29, 2024 | 
thefdalawblog.com | John W.M. Claud
There is a growing consensus among legal experts that after Loper Bright, FDA may rely on non-binding guidance to instruct industry with hopes of charting regulatory pathways that avoid litigation. In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters.
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Jul 21, 2024 | 
thefdalawblog.com | John W.M. Claud
Sometimes it’s difficult to be a plaintiff, putting all your work into just one case. That’s especially true if recent Supreme Court rulings have rendered your matter a quixotic pursuit, doomed to fail for lack of direct causation. That’s what happened last week in District Court in Maryland. Following the precedent on standing that the Supreme Court handed down in June in FDA v. Alliance for Hippocratic Medicine et al., a judge in Maryland dismissed another suit against FDA for lack of standing.
