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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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

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: 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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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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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 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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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 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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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

JUNE 17, 2024

One biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.

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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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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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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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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

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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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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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

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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thought leadership

SEPTEMBER 26, 2024

On May 6, 2024, the US Food and Drug Administration (FDA) issued the Final Rule regarding regulation of laboratory developed tests (LDTs). The LDT Final Rule outlines a four-year phaseout period for the enforcement discretion approach that FDA has previously exercised for LDTs.

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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

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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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

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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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). Consider, for example, a Complaint filed just recently in the U.S.

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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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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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BioPharma Drive: Drug Pricing

SEPTEMBER 26, 2024

The letter follows a New York Times report that raised concerns about Jeff Shuren’s potential conflicts of interest as head of the FDA’s device center.

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FDA 52

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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Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

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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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BioPharma Drive: Drug Pricing

SEPTEMBER 12, 2024

based F2G complete late testing of a treatment that the FDA rejected one year ago. The funding, from AMR Action Fund and others, will help U.K.

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FDA Treatment Drugs 62

Eye on FDA

JULY 29, 2021

The scope of the story and the revelations underlying indicate that FDA is experiencing a crisis. At least judging from the reporting, the FDA narrative has not always been consistent. The agency’s response so far does not. This is an abbreviated list. Moreover, the narrative must be consistent.

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BioPharma Drive: Drug Pricing

SEPTEMBER 18, 2024

The FDA’s clearance could double Kisqali’s breast cancer market. Elsewhere, Novo is exploring new ways to deliver genetic therapies and Bain is funding a growing CDMO.

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ProRelix Research

NOVEMBER 27, 2023

The United States Food and Drug Administration (FDA) has strict regulations regarding pharmacovigilance activities that are a part of post-marketing studies for drugs and medical devices that are required as […] The post FDA Pharmacovigilance Regulations Update appeared first on ProRelix Research.

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Drugs.com

AUGUST 30, 2023

August 28, 2023 -- FDA has approved several first generics of Vyvanse (lisdexamfetamine dimesylate) capsules and chewable tablets for attention-deficit/hyperactivity disorder (ADHD) in patients six years and older and moderate to severe binge-eating.

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