FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

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Drugs.com

DECEMBER 22, 2023

The FDA said Thursday that it has seized thousands of. FRIDAY, Dec. 22, 2023 -- The U.S. Food and Drug Administration has uncovered counterfeit Ozempic shots in the legitimate U.S. drug supply chain, and is warning patients to be on their guard.

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BioPharma Drive: Drug Pricing

OCTOBER 31, 2023

The high-profile meeting focused on the theoretical risks of CRISPR gene editing, as both the FDA and its advisory committee appeared convinced by the efficacy of the companies’ exa-cel treatment.

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BioPharma Drive: Drug Pricing

DECEMBER 8, 2023

In addition to clearing Vertex Pharmaceuticals and CRISPR Therapeutics’ Casgevy, the FDA also granted an early OK to Bluebird bio’s sickle cell treatment Lyfgenia.

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BioPharma Drive: Drug Pricing

JUNE 4, 2024

A group of independent experts wasn't convinced by clinical trial data from company Lykos Therapeutics, which is seeking FDA approval of MDMA-assisted treatment for post-traumatic stress disorder.

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Drugs.com

JULY 29, 2024

late May, an FDA advisory panel had voted 7-2 that the benefits outweigh the risks when using the Guardant Health's. MONDAY, July 29, 2024 -- The U.S. Food and Drug Administration on Monday approved a new blood test that can spot colon cancer.In

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BioPharma Drive: Drug Pricing

OCTOBER 23, 2023

since late last year as the FDA sought more details on Verve’s in vivo treatment for heart disease. The trial, which is ongoing in the U.K. and New Zealand, has been on hold in the U.S.

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Crown Bioscience

JUNE 6, 2024

In a significant development, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 55 new drugs in 2023. This marks the second-highest count in the past 30 years, with the highest being 59 new drug approvals in 2018 and represents an impressive 50% increase in drugs approved in 2022.

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BioPharma Drive: Drug Pricing

APRIL 5, 2024

The FDA’s clearance comes three weeks after a panel of advisers endorsed expanded use of Abecma despite safety concerns raised by the agency.

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BioPharma Drive: Drug Pricing

JUNE 9, 2023

In a 6-0 vote, a group of independent advisers agreed recent clinical trial data confirmed the drug’s benefit, paving the way for an FDA decision early next month.

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Drugs.com

JULY 30, 2024

Food and Drug Administration warns.These ODs typically are due to miscommunications or miscalculations regarding dosage, the FDA. TUESDAY, July 30, 2024 -- People taking compounded versions of Ozempic have been overdosing on the drug, the U.S.

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FDA Law Blog: Drug Discovery

JULY 17, 2024

Importantly, the Hub is intended to establish a new model within FDA, which leverages cross-Agency expertise in providing guidance and conducting reviews for products for rare disease populations. By Sarah Wicks & James E. Valentine & Frank J. those reviewed by the CDER Division of Rare Diseases and Medical Genetics).

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Drugs.com

AUGUST 1, 2024

FDA is warning consumers not to purchase or use. THURSDAY, Aug. 1, 2024 -- Don't use a chemical peel to help rejuvenate your skin unless it's done under the supervision of a trained professional, the U.S. Food and Drug Administration has advised.

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BioPharma Drive: Drug Pricing

NOVEMBER 29, 2023

Bumpus, a former Johns Hopkins professor, named “creating a new model” for the FDA’s Office of Regulatory Affairs as one of her priorities when she steps into the role.

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BioPharma Drive: Drug Pricing

SEPTEMBER 25, 2023

Agency scientists flagged numerous issues with Brainstorm’s stem cell treatment ahead of a high-profile Wednesday meeting of expert FDA advisers.

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BioPharma Drive: Drug Pricing

NOVEMBER 22, 2024

A prolific medical research and author, Martin Makary criticized the FDA and CDC for their decision-making during the pandemic, although he describes himself as pro-vaccine.

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FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

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Drug Patent Watch

AUGUST 29, 2024

Ensuring that a generic drug meets FDA standards is crucial for maintaining the high quality and efficacy of medications. The FDA’s Office of Generic Drugs (OGD) plays a vital role in this process by following a rigorous review process to ensure that generic medications meet the same standards as their brand-name counterparts.

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FDA Law Blog: Biosimilars

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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Drugs.com

MARCH 19, 2024

DuOtic is also the first ear infection medication that does not contain an antibiotic, the FDA said in its approval. Food and Drug Administration has approved the first drug to treat yeast ear infections in dogs.

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Drugs.com

DECEMBER 18, 2024

Food and Drug Administration (FDA) has issued its most serious warning -- a black-box warning -- for Veozah, a medication used to relieve hot flashes in menopausal women, due to rare but potentially severe liver. WEDNESDAY, Dec. 18, 2024 -- The U.S.

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BioPharma Drive: Drug Pricing

DECEMBER 17, 2024

An FDA approval of Merck’s drug clesrovimab by June would give physicians another option for protecting newborns from respiratory syncytial virus.

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thought leadership

SEPTEMBER 5, 2024

Congratulations, FDA has approved your PMA! Securing a Premarket Approval (PMA) from the FDA is a significant achievement for any medical device manufacturer—a validation of your product's safety and effectiveness. But the journey doesn't end there.

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FDA Law Blog: Biosimilars

FEBRUARY 9, 2024

Baumhardt, Senior Medical Device Regulation Expert — As an end of the year gift, FDA finalized its guidance document, Digital Health Technologies for Remote Data Acquisition in Clinical Investigations , in late December. c) a submission of an IDE to the FDA is not required. c) a submission of an IDE to the FDA is not required.

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Drugs.com

JUNE 11, 2024

an advisory, the FDA told. TUESDAY, June 11, 2024 -- Seafood lovers should steer clear of shellfish from Oregon and Washington state because of possible contamination with a paralyzing toxin, the U.S. Food and Drug Administration has warned.In

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Drugs.com

SEPTEMBER 19, 2024

Food and Drug Administration warns.This inaccurate labeling could put people with milk allergies in danger, the FDA no. THURSDAY, Sept. 19, 2024 -- Consumers should be aware that some chocolate labeled as “dairy-free” actually contains milk, the U.S.

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thought leadership

JULY 31, 2024

It's human nature to panic when the law enforcement (or in this case the US FDA) tells you that you've done something wrong. You may have believed that you had done nothing wrong. Regardless of the specific situation, you probably panicked a little.

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BioPharma Drive: Drug Pricing

JULY 2, 2024

The drug, which Lilly will sell as Kinsunla, carries a warning for the risk of a certain kind of imaging abnormality that can be serious in rare cases.

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Drug Patent Watch

SEPTEMBER 12, 2024

In the labyrinthine world of pharmaceuticals, where the cost of life-saving medications can often feel like a roll of the dice, the FDA is implementing a strategy that aims to bring some much-needed transparency and affordability to the market.

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Drugs.com

FEBRUARY 1, 2024

THURSDAY, Feb. 1, 2024 -- Certain copycat eyedrops may be contaminated and could give users an antibiotic-resistant eye infection, the U.S. Food and Drug Administration warned Wednesday.The packaging for South Moon, Rebright and FivFivGo eyedrops.

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BioPharma Drive: Drug Pricing

JUNE 7, 2024

A vote against MDMA-assisted therapy set back a high-profile treatment. Proponents argue the panel offered few solutions to longstanding problems, making the path forward unclear.

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BioPharma Drive: Drug Pricing

MARCH 14, 2024

Rezdiffra’s clearance is a turning point in the fight against the liver disease. But its sales potential is unclear, and competition could emerge from popular weight loss drugs.

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BioPharma Drive: Drug Pricing

NOVEMBER 18, 2024

The agency's openness to a targeted pivotal study shows it’s still willing to consider accelerated clearance for Duchenne gene therapies despite questions about their effectiveness.

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BioPharma Drive: Drug Pricing

JUNE 20, 2024

The agency has lifted a partial trial suspension based on one-year data showing PTC’s pill suppressed a key protein associated with the disorder.

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BioPharma Drive: Drug Pricing

JULY 3, 2024

Multibillion-dollar buyouts from Bristol Myers Squibb and Gilead could yield new drugs for brain and liver diseases, while a new cell therapy may reach market.

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Drugs.com

AUGUST 22, 2024

THURSDAY, Aug. 22, 2024 -- Updated shots to shield against COVID-19 infection were approved by the U.S. Food and Drug Administration on Thursday.This year's approval for the updated mRNA vaccines comes much sooner than happened in 2023, when fall.

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BioPharma Drive: Drug Pricing

JANUARY 4, 2024

The agency could soon clear important new drugs from Eli Lilly and Merck, as well as the first treatment for a common liver disease.

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