STAT

JULY 15, 2024

Two FDA officials, Haider Warraich and Robin McKinnon, met multiple times in February to discuss regulating these edible industrial creations, such as sodas, prepackaged cookies, and most breakfast cereals. Warraich serves as a senior adviser to FDA commissioner Robert Califf. Continue to STAT+ to read the full story…

Documentation 145

Documentation FDA 145

STAT

MAY 1, 2024

In study documents, Mount Sinai doctors said the biopsies result in “the same amount of tissue loss” and “in effect, the same level of risk” for patients as standard DBS, because they are removing tissue that would otherwise be cauterized.

Documentation 145

Documentation FDA Nursing Homes 145

STAT

SEPTEMBER 19, 2024

Specifically, a “large number of torn pieces” of documents that should have been kept to verify manufacturing and testing practices were found in the trucks, as well as in a scrap bag at a site run by Granules in Telangana, India.

Documentation 111

Documentation FDA Generic Medicine 111

STAT

DECEMBER 30, 2024

  The new research analyzed paperwork submitted for FDA approval to market a device for 767 oximeters that had been approved between 1978-2024 and had accessible information about performance testing.

Documentation 138

Documentation FDA 138

Drug Topics

JUNE 11, 2025

READ MORE: FDA Approves Roflumilast Foam For Plaque Psoriasis of Scalp, Body The current treatment guidelines for patients with psoriasis include a variety of pharmacological options, such as biologics, phototherapy, and topicals. of the population across the region,” wrote authors of the study.

Immunization 315

Immunization Documentation Specialty Pharmacies Compounding 315

STAT

JANUARY 7, 2025

The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs.

FDA 100

FDA Compounding Documentation 100

STAT

OCTOBER 27, 2023

None of the concerns raised by the FDA on Friday, however, suggest the agency is reluctant to approve the treatment, called exa-cel, which is being developed by Vertex Pharmaceuticals and CRISPR Therapeutics.

Documentation 141

Documentation FDA 141

PharmaVoice

APRIL 30, 2025

A leaked document revealed details about changes that could impact how the agency operates, but recent comments from FDA Commissioner Dr. Marty Makary have muddied the picture.

FDA 147

FDA Documentation 147

STAT

MAY 10, 2023

Reviewers at the Food and Drug Administration concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns, according to briefing documents released Wednesday.

Documentation 100

Documentation FDA 100

Drug Topics

JULY 8, 2025

TCSs are the first-line anti-inflammatory treatment and their effectiveness and safety have been well documented.” The next step consists of treatment with topical anti-inflammatory therapies. Above all other medication classes and formulations, TCSs have been deemed as the most important pharmacotherapy in the treatment of AD.

247

247

STAT

OCTOBER 6, 2022

In the run-up to an extremely unusual hearing later this month, newly released documents underscore highly contrasting views taken by the U.S. For the first time, the FDA has explained in copious detail why agency officials believe the medication, which is called Makena, should be removed.

Documentation 100

Documentation FDA 100

The FDA Law Blog

JULY 8, 2025

Snow — Recently, FDA announced a deadline shift, although the Agency did so quietly. Confirmatory testing remains due by August 1, 2025, but FDA has now acknowledged that full implementation of mitigation strategies—such as reformulation or the addition of new specifications—may take longer. By Charles D. What does this mean?

52

52

STAT

OCTOBER 22, 2024

Compounding pharmacies are typically allowed to make copies of drugs that are deemed to be in shortage by the FDA, which semaglutide has been for over two years. The FDA still has to make a decision on whether to officially place semaglutide on the lists. The agency did not immediately respond to a request for comment.

Compounding 144

Compounding Compounding Pharmacies FDA Documentation 144

STAT

JANUARY 7, 2025

The advent of the first generic GLP-1 drugs could help Medicare negotiate a lower price for the highly sought after diabetes and obesity medication semaglutide , according to experts familiar with the price-negotiation program and STAT’s review of documents from the first round of negotiations.

Documentation 127

Documentation Insurance FDA 127

Drug Topics

JUNE 25, 2025

image credit: syahrir / stock.adobe.com While data shows that obesity has been on the rise among children in recent history, the overall complications spurred on by childhood obesity have been well documented. 1 “Guidelines recommend treating obesity with medications and lifestyle changes.”

Compounding 315

Compounding Insurance Coverage Insurance Specialty Pharmacies 315

BioPharm

MAY 3, 2024

A new draft guidance issued by FDA covers human- and animal-derived materials used in the manufacture of advanced therapy medicinal products.

Documentation 111

Documentation FDA 111

Pharmafile

JANUARY 20, 2023

India-based manufacturer Intas Pharmaceuticals has been issued a Form 483 by the FDA after three investigators found a “cascade of failure” in a site inspection carried out at their manufacturing facility in Pharmez Special Economic Zone (SEZ) between late November and early December 2022. read more

Documentation 94

Documentation FDA 94

pharmaphorum

SEPTEMBER 28, 2022

The US FDA’s Center for Devices and Radiological Health (CDRH) dropped a bevy of new digital health guidances and reports today and yesterday, providing some long-awaited clarity and peeks into the agency’s future plans. . The push started yesterday with the 31-page key findings report from the FDA Pre-Certification Program pilot.

FDA 135

FDA Documentation 135

The FDA Law Blog

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.

Documentation 59

Documentation FDA Communication 59

STAT

SEPTEMBER 25, 2023

BrainStorm filed for approval over the FDA’s protest, insisting that NurOwn has demonstrated benefits for a subset of ALS patients with milder disease.

FDA 138

FDA Documentation 138

STAT

JUNE 20, 2024

On Thursday evening, the FDA announced it expanded the approval of Elevidys, Sarepta’s Duchenne gene therapy, to cover nearly all patients, regardless of age or wheelchair status, despite the fact that the drug failed a large, Phase 3 trial last year. 

FDA 145

FDA Documentation 145

Fierce Pharma

JUNE 6, 2024

When the FDA comes knocking at your drug manufacturing facility, it’s best to play along. |

FDA 119

FDA Documentation 119

STAT

JUNE 25, 2024

The company also received FDA clearance for KAI 12L, the software that can analyze ECGs to detect up to 35 conditions including arrhythmias, like atrial fibrillation, and other issues, like heart attacks.

FDA 136

FDA Documentation Hospitals 136

Fierce Pharma

SEPTEMBER 11, 2024

Ahead of an advisory committee meeting slated for Friday, the FDA unleashed damning briefing documents calling into question the effectiveness and safety of Intercept’s rare liver disease drug Ocaliva. For Intercept Pharmaceuticals’ beleaguered liver disease drug Ocaliva, the hits just keep coming.

FDA 111

FDA Documentation 111

The FDA Law Blog

APRIL 10, 2025

Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. However, not all information contained in FDA records is disclosable.

FDA 59

FDA Documentation Packaging Communication 59

European Pharmaceutical Review

AUGUST 23, 2022

A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.

FDA 105

FDA Documentation Packaging Labelling 105

Fierce Pharma

OCTOBER 3, 2023

As an FDA advisory committee gears up to discuss the data supporting Amgen’s Lumakras, a pre-meeting briefing document from the agency suggests the KRAS inhibitor might have a tough road ahead. |

FDA 110

FDA Documentation 110

European Pharmaceutical Review

MARCH 13, 2024

FDA inspections Identification of data integrity deviations Of the 70 Warning Letters issued by the US Food and Drug Administration (FDA) so far in 2024, three have identified data integrity issues at pharmaceutical manufacturing sites outside the US. In a letter issued to China-based Sichuan Deebio Pharmaceutical Co.

FDA 98

FDA Documentation 98

STAT

MAY 16, 2023

An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the Food and Drug Administration said Tuesday in an analysis of the data generated to support licensure of the vaccine.

Vaccines 98

Vaccines Documentation FDA 98

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA 98

FDA Documentation Method Validation Packaging 98

pharmaphorum

DECEMBER 9, 2020

Reviewers from the FDA have given their blessing to the Pfizer/BioNTech COVID-19 vaccine ahead of a key meeting tomorrow – but the regulator noted that there are still uncertainties about whether the shot can stop the disease from spreading. The post FDA reviewers back Pfizer/BioNTech COVID-19 vaccine ahead of panel appeared first on.

Vaccines 111

Vaccines FDA Adverse Reactions Documentation 111

pharmaphorum

JUNE 10, 2022

If you work in pharma, the chances are you’re no stranger to the United States Food and Drug Administration, or FDA, which regulates pharmaceuticals. While the FDA is responsible for regulating both drugs and devices, they’re handled through completely different processes in different parts of the agency.

FDA 133

FDA Documentation 133

STAT

OCTOBER 20, 2023

The list of AI devices was first published after a STAT investigation reported that the FDA had failed to keep the public informed on its regulation of AI devices, or crucial details on the tests undertaken to prove their safety and effectiveness.

FDA 119

FDA Documentation 119

The FDA Law Blog

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.

FDA 111

FDA Communication Documentation 111

pharmaphorum

DECEMBER 23, 2021

The FDA has published draft guidance on how digital health technologies (DHTs) like smart and wearable devices can be used to capture data remotely from patients in clinical trials – an approach that has come to the fore since the start of the pandemic. The draft is open for comment until 22 March.

FDA 118

FDA Documentation 118

The FDA Law Blog

NOVEMBER 6, 2023

Lewis, Senior Regulatory Device & Biologics Expert — We were preparing this blogpost about FDA’s draft guidance on “Remote Interactive Evaluations” when we learned something. Compared with the COVID-centered version of the document released in April 2021, there is very little that is new or different.

FDA 105

FDA Documentation Medical Records 105

STAT

JUNE 8, 2023

” FDA staff said that data from a late-stage trial of Eisai and Biogen’s Alzheimer’s drug suggests it offered a meaningful benefit to patients and safety concerns likely would not hamper its chances of a traditional approval , Reuters reports. The FDA decision is expected by July 6.

FDA 98

FDA Documentation Insurance 98