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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Drugs.com

MARCH 6, 2024

The FDA urged folks to throw away and not buy the following brands of. WEDNESDAY, March 6, 2024 -- The U.S. Food and Drug Administration issued a health advisory Wednesday warning consumers that six brands of ground cinnamon are tainted with lead.

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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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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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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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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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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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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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FDA Law Blog: Biosimilars

FEBRUARY 2, 2024

Mullen — On January 31, 2024, FDA announced its intent to initiate the reclassification process for most in vitro diagnostic (IVD) products that are currently class III (high risk) into class II (moderate risk). This is to say nothing of the expected doubling of annual device submissions FDA expects it will then receive on an ongoing basis.

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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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FDA Law Blog: Biosimilars

NOVEMBER 4, 2024

More specifically, FDA rescinded approval of a “regulatory method” that Phibro used to establish that carbadox is safe and effective. Phibro requested a hearing, and though the then-CVM Director recommended granting the hearing, FDA never did. Phibro filed the instant lawsuit.

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FDA Law Blog: Biosimilars

SEPTEMBER 22, 2024

The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ).

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thought leadership

JULY 24, 2024

Sponsors need to adapt the way they create and compose 510(k)s because the eSTAR software presents different challenges compared to FDA's old eCopy format. Implementing the eSTAR Format The eSTAR template is a positive step for both CDRH and medical device Sponsors; but, as with any new tool, there are challenges to utilizing the template.

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Eye on FDA

FEBRUARY 8, 2024

Every so often is it worthwhile to look back at FDA to see what they had to say in a given year, and in addition, how they said it. In fact, the use of FDA Roundups appears to be on the rise, and this might be a factor in fewer traditional press releases coming out of FDA. Less is more? What Did They Talk About?

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ProRelix Research

NOVEMBER 5, 2024

Successful […] The post Clinical Trials and Human Subject Protection as per US FDA appeared first on ProRelix Research. Clinical trials are necessary in advancing medical research and health care options by allowing new treatments to be introduced in the market through safety and efficacy testing in humans.

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BioPharma Drive: Drug Pricing

APRIL 1, 2024

The FDA could soon expand use of two multiple myeloma cell therapies as well as a top-selling medicine from Sanofi and Regeneron, while Pfizer’s years of gene therapy work might finally pay dividends.

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FDA Law Blog: Biosimilars

SEPTEMBER 16, 2024

Schwartz — FDA recently published a Federal Register (FR) Notice [ Docket No. FDA-2024-N-3945 ] announcing the publication of a draft strategy document, for public comment, outlining specific actions FDA plans to take to facilitate the use of innovative manufacturing technologies.

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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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The Premier Consulting Blog

OCTOBER 30, 2024

It is recognized, however, that there is a learning curve across the industry and FDA that is inherent to the development of such novel technologies. To prevent this learning curve from becoming a roadblock on the path to regulatory approval, the FDA has developed several collaborative programs to support advanced manufacturing.

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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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ProRelix Research

AUGUST 3, 2023

Although the United States Food and Drug Administration (FDA) has always supported and advocated the idea of decentralized trials, the real adoption and application of decentralized aspects in trials has […] The post FDA Guidance on Advancement of Decentralized Clinical Trials appeared first on ProRelix Research.

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FDA Law Blog: Biosimilars

SEPTEMBER 12, 2024

Walsh — While we hope readers of the Blog, as our clients and friends, come out of any FDA inspection with a clean bill of health, we know that based on FDA FY2024 data to date, approximately 40% of inspections of medical device companies end up classified as voluntary or official action indicated (VAI or OAI).

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Eye on FDA

AUGUST 4, 2021

As more drugs are being approved, is FDA getting less advice than in the past? FDA maintains a vast network of outside advisors to provide input and counsel to the agency related to decisions on policy as well as product approvals. There are 31 advisory committees on matters ranging from food to medical devices to pediatric care.

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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

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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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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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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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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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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Eye on FDA

OCTOBER 12, 2023

FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new advisory committees all that often, making it a notable development in more than one respect.

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BioPharma Drive: Drug Pricing

JULY 11, 2024

The FDA’s decision to turn back the drugmaker’s new insulin product narrows Novo’s lead in the U.S. over Eli Lilly, which has a similar diabetes treatment in late-stage testing.

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Eye on FDA

MARCH 7, 2024

Back in December 2023, FDA announced intention in the Federal Register and in a press release to form a new FDA Advisory Committee to be called the Genetic Metabolic Diseases Advisory Committee (GeMDAC). GeMDAC at this time does not have any members appointed.

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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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Eye on FDA

AUGUST 10, 2023

Every six months, we do a look-back to see what has changed in the way that FDA is communicating. The number of press releases issued by FDA during the first six months of the year declined to 101 from the 125 issued by June 30 of last year, the lowest number at mid-year since 2017. And there is more to tell.

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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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BioPharma Drive: Drug Pricing

AUGUST 22, 2024

The FDA backed Jeff Shuren, the agency’s former CDRH leader, amid questions raised by The New York Times. Still, a spokesperson said the FDA has advised Shuren to take greater caution in managing recusal obligations.

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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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