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 101

Documentation FDA 101

The FDA Law Blog

DECEMBER 8, 2022

Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g.,

Documentation 59

Documentation Labelling FDA Packaging 59

Fierce Pharma

JUNE 6, 2024

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

FDA 103

FDA Documentation 103

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

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

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 84

FDA Documentation 84

Outsourcing Pharma

JANUARY 28, 2022

A representative from IQVIA discusses the particulars of the US agencyâs new draft document and shares what it might mean for clinical trial data evaluation.

Documentation 69

Documentation FDA 69

BioPharm

MARCH 23, 2023

The recent document will guide the use of DHT-derived data in regulatory decision-making for drugs and biological products.

Documentation 59

Documentation FDA 59

STAT

JANUARY 23, 2023

Scientists at the Food and Drug Administration propose making Covid vaccination a regular, once-a-year shot that is updated to match current strains of the SARS-CoV-2 virus, according to documents posted by the FDA on Monday. For people who are older or immunocompromised, the FDA would recommend two annual doses of the revised shot.

FDA 136

FDA Documentation Vaccines 136

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 141

FDA Documentation 141

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

STAT

JUNE 25, 2024

Upon reviewing the FDA’s and Lykos’ briefing documents, the Psychopharmacologic Drugs Advisory Committee deemed the study data insufficient to approve the application, and it determined that the company’s risk evaluation and mitigation strategy did not fully address potential harms of this therapy.

Documentation 107

Documentation FDA 107

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 92

FDA Documentation 92

BioPharm

JUNE 21, 2024

The guidance document provides information about the agency’s intentions for assigning a goal date for a facility’s inspection readiness under GDUFA.

Documentation 52

Documentation FDA 52

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

BioPharm

JANUARY 11, 2023

A REMS document is a part of a REMS required by FDA and establishes the goals and requirements of the REMS.

Documentation 40

Documentation FDA 40

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

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 125

FDA Documentation 125

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

STAT

SEPTEMBER 26, 2023

As a government shutdown looms, FDA published a contingency plan stating it will immediately have to furlough 19% of its staff until it receives more funds. Food and Drug Administration will have to furlough almost one-fifth of its staff and halt work that could have a critical impact on medical-products industries , Regulatory Focus says.

FDA 107

FDA Documentation 107

The FDA Law Blog

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.

FDA 105

FDA Documentation 105

STAT

JUNE 6, 2023

Notably, the FDA inspectors found a truck that was waiting for clearance to leave the facility and was carrying plastic bags that contained shredded documents. The inspectors found issues with data integrity and procedures designed to prevent microbiological contamination, among other problems.

Chemotherapy 101

Chemotherapy FDA Documentation 101

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 86

FDA Documentation Packaging Labelling 86

The FDA Law Blog

JUNE 27, 2023

Walsh — Last fall, we blogged about the process FDA uses to review allegations of regulatory misconduct against device manufacturers, suggesting greater transparency on the FDA process was needed (see here ).

FDA 59

FDA Documentation Labelling Communication 59

STAT

FEBRUARY 28, 2024

antitrust regulators into pharmaceutical industry middlemen has been stymied because the companies have failed to provide many of the documents that, in some cases, were requested as far back as June 2022 , STAT writes. The … A much-anticipated inquiry by U.S.

FDA 123

FDA Documentation Insurance 123

STAT

NOVEMBER 17, 2023

They were approved under the FDA accelerated pathway in 2009 and 2014, respectively, for treating a rare form of blood cancer. The  The company’s final study plan was submitted to the FDA in 2022 and is expected to be completed  by 2030 , according to FDA briefing documents published earlier this week.

FDA 104

FDA Documentation 104

STAT

JANUARY 3, 2023

A House investigation released last week unearthed a trove of documents that shed new light on the polarizing approval and disastrous rollout of Aduhelm, the first new drug for Alzheimer’s disease in two decades.

FDA 98

FDA Documentation 98

PharmExec

NOVEMBER 7, 2023

House Committee on Oversight and Accountability request documents on agency’s drug shortage mitigation strategies.

Documentation 98

Documentation FDA 98

BioPharm

MAY 2, 2024

Guidance documents and interaction with FDA can help manufacturers stay in GMP compliance, says Siegfried Schmitt, VP Technical, at Parexel.

Documentation 69

Documentation FDA 69

pharmaphorum

DECEMBER 30, 2022

The FDA’s interactions with Biogen in the build-up to last year’s controversial approval of Alzheimer’s disease therapy Aduhelm have been described as “inappropriate” and “atypical” in a congressional report on the review.

FDA 59

FDA Documentation Labelling 59

STAT

JUNE 9, 2023

At the meeting, the FDA is asking six independent experts to review a subsequent and larger Phase 3 clinical trial and vote on whether the results confirm Leqembi’s benefit. In documents released this week, FDA reviewers appeared receptive to granting full approval to Leqembi. Track the meeting here and here.

FDA 96

FDA Documentation Vaccines 96

The FDA Law Blog

JULY 10, 2023

After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.

FDA 75

FDA Documentation Packaging Communication 75

pharmaphorum

NOVEMBER 25, 2022

The FDA has issued a complete response letter (CRL) to Spectrum Pharma for poziotinib, its pan HER2 inhibitor for a form of lung cancer, according to South Korea’s Hanmi Pharma, which originally developed the drug. The post FDA rejects Spectrum’s lung cancer drug poziotinib appeared first on.

FDA 98

FDA Documentation 98

Pharmafile

MARCH 21, 2023

It appears that the FDA is inclined to support Biogen’s amyotrophic lateral sclerosis (ALS) drug, tofersen, with documents released on Monday stressing the need for “regulatory flexibility” when assessing treatments for life threatening diseases such as ALS. read more

FDA 59

FDA Documentation Communication 59

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

The FDA Law Blog

JUNE 20, 2023

Mullen — On June 2, 2023, FDA issued the latest version of its guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program. The document provides minor updates on procedures, incorporating recent developments and experiences in how FDA interacts with industry.

FDA 45

FDA Documentation Communication 45

The FDA Law Blog

OCTOBER 27, 2022

Lewis, Senior Regulatory Device & Biologics Expert — FDA recently published the final guidance document “ Comparability Protocols for Postapproval Changes to the Chemistry, Manufacturing, and Controls Information in an NDA, ANDA, or BLA.” By Holly N. Brevig, Senior Regulatory Device and Biologics Exper & Richard A.

FDA 105

FDA Documentation 105