The FDA Law Blog

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. For example, FDA granted seven De Novos for COVID-19 related indications for use. In effect, these documents serve as road signs helping to direct new market entrants.

FDA 69

FDA Documentation Hospitals 69

pharmaphorum

JULY 27, 2022

The paper, by a team from Imperial College London, concluded that the FDA gave the go ahead to 95% of the 89 products approved between 2010 and 2019 before EMA, with the Europeans trailing the Americans by a median of 241 days. Between 2012 and 2020, it averaged 3% each year, whereas Spain’s share, for example, had increased from 2.6%

Documentation 98

Documentation FDA 98

The FDA Law Blog

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.

FDA 59

FDA Documentation 59

European Pharmaceutical Review

JULY 4, 2023

Since the first ADC was approved by the EMA in 2012, they have generated a great deal of interest in the oncology field because of their potential to address many of the challenges of traditional chemotherapy options.

Communication 98

Communication Chemotherapy Documentation Dosage 98

The Checkup by Singlecare

DECEMBER 1, 2023

Food and Drug Administration (FDA) certifies the Red Dye 40 as safe for human consumption. Apart from Red Dye 40, there are eight other certified color additives approved for use in food by the FDA: Blue No. The FDA has denied any link between the two for years. The controversy surrounding Red Dye 40 The U.S. 1, Blue No.

Labelling 52

Labelling FDA Documentation 52

The Spirit Pharmacist

FEBRUARY 21, 2023

The only FDA approved treatment for post-partum depression is a progesterone analogue that must be delivered over a 60-hour IV infusion and appears mildly efficacious. There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23].

Documentation 98

Documentation Compounding Immunization FDA 98

Policy Prescription

APRIL 1, 2022

To the extent that SafeChain sold any counterfeit medication, SafeChain was an unwitting participant and notified the FDA of customer complaints as required by law. Where’s the FDA? Where was FDA enforcement during this period, when patients were being dosed with dangerous counterfeits? Time will tell. . Emphasis added).

FDA 40

FDA Documentation 40

ISPE

SEPTEMBER 12, 2022

FDA/CBER/OMPT/OCBQ. And I'd like to make industry aware of a PIC/S document that's intended to guide inspectors on good data governance practices. Director, Office of Pharmaceutical Quality Operations. 2022 PIC/S Chair, Sr. Corporate Regulatory Compliance & Enforcement Advisor. Rick Friedman. Brooke Higgins. Robert Sausville.

FDA 52

FDA Documentation Communication 52

ISPE

JANUARY 11, 2023

January 2012. 5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

SEPTEMBER 8, 2023

USA The FDA established the Emerging Technology Program (ETP) in 2014 and has actively promoted the program 8. Published May 2012. www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program 9 US Food and Drug Administration Center for Drug Evaluation and Research. 22 June 2023. 22 June 2023.

FDA 52

FDA Documentation Dosage Communication 52

ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). A formal change control system under the company’s pharmaceutical quality system (PQS) is required to evaluate all raw material changes, with established procedures for identification, documentation, review, and approval.

Documentation 52

Documentation FDA Packaging Communication 52

ISPE

OCTOBER 28, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. The outcomes of these inspections were shared extensively with MRA partners such as EMA and US FDA. Canada DHPID ). Canada DHPID ).

FDA 97

FDA Vaccines Documentation Dosage 97

pharmaphorum

SEPTEMBER 13, 2022

The first well-documented case of multiple myeloma was reported in 1844 by renowned British surgeon Samuel Solly. 2001– FDA green lights revolutionary treatments. Just over a decade after it was developed by biochemist Nicholas Lyndon, Imatinib received US Food and Drug Administration (FDA) approval in 2001.

Chemotherapy 98

Chemotherapy Immunization FDA Documentation 98

The Thyroid Pharmacist

JULY 14, 2023

All Lumebox products are FDA-registered, follow the Good Manufacturing Practice (GMP) system, and every batch is third-party tested. This Class II medical device is FDA-cleared and meant to target all kinds of pain. Various red light therapy devices have also hit the market which are generally FDA-approved. doi:10.1089/thy.2010.0102;

Dosage 98

Dosage FDA Immunization Documentation 98

ISPE

NOVEMBER 21, 2022

It was usual practice for TGA to prepare additional guidance/explanatory documents for industry and for TGA inspection staff to participate in training seminars to assist industry. The outcomes of these inspections were shared extensively with MRA partners such as EMA and US FDA. The approach by TGA and HSA were very similar.

FDA 52

FDA Vaccines Documentation Dosage 52

The Thyroid Pharmacist

JULY 29, 2022

This article of mine discusses 19 thyroid-toxic products that have been banned by the FDA. Feel free to use my own health timeline as a guideline to document your health journey. doi: 10.1515/jcim-2012-0020. 2012; 57: 120-125. Nahar T, Uddin B, Hossain S, Sikder AM, Ahmed S. J complement Integr Med. Int J Mol Sci.

Health and Personal Care Stores 52

Health and Personal Care Stores Compounding Immunization Labelling 52

The FDA Law Blog

JANUARY 9, 2025

Farquhar This is the first in a series of blog posts on tips for successfully handling an FDA inspection. Using publicly available examples, these lessons will illustrate potential pitfalls and strategies for interacting with FDA during and after an inspection. FD&C Act 501(j).

FDA 105

FDA Documentation Labelling 105

The FDA Law Blog

DECEMBER 1, 2024

Farquhar — A recent Warning Letter reflects an FDA citation of a company for refusing to permit FDA Investigators to take photographs during an inspection. FDA reports that it told the company that “failure to allow photography would be documented as a refusal,” and the company “acknowledged the refusal.” By Douglas B.

FDA 113

FDA Documentation Labelling 113

European Pharmaceutical Review

APRIL 8, 2025

To give examples, such a work package focuses on the identification of regulations (ICH Q2 R2, 3 Q8-Q14, 4-10 FDA PAT guidance, 11 EMA Annex 15 12 ), some of which may be mainly guidance documents with recommendations and flexibility when it comes to PAT.

Documentation 52

Documentation Packaging FDA 52

The Thyroid Pharmacist

JANUARY 20, 2023

In 1998, the Food and Drug Administration (FDA) defined an adaptogen as a new kind of metabolic regulator that has been proven to help in environmental adaptation and to prevent external harms. doi:10.1155/2012/674142 [56] Meena H, Pandey HK, Arya MC, Ahmed Z. Phytother Res. 2014;28(4):475-479. doi:10.1002/ptr.5018 2012;2012:674142.

HIV Treatment and Prevention Agents 98

HIV Treatment and Prevention Agents Immunization Compounding Documentation 98