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.

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FDA Documentation Packaging Labelling 98

Fierce Pharma

AUGUST 2, 2023

Intas Pharmaceuticals’ new warning letter from the U.S. FDA reads like a checklist of what not to do when the regulator pays a visit to your manufacturing facility. | The FDA handed Intas a five-observation write up after inspecting the company’s Sanand, India, production plant from November 22 to December 2, 2022.

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FDA 98

PharmExec

NOVEMBER 15, 2023

The eye drops listed in the warning letter are defined as drugs because they are intended to use for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure of any function of the body.

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FDA 75

PharmExec

AUGUST 16, 2023

In its second warning letter issued in 2023, the FDA has sternly cautioned AstraZeneca for misleading claims in the promotional materials of its Breztri Aerosphere inhalation aerosol; this marks the first warning letter AstraZeneca has received this year.

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Communication FDA 52

Pharmaceutical Technology

NOVEMBER 22, 2023

The warning letter issued to Cipla will further delay the launch timelines of the company’s Advair generic in the US.

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FDA 52

The FDA Law Blog

AUGUST 10, 2023

Cato — On August 3rd, FDA issued 11 warning letters to foreign facilities registered as OTC drug manufacturers. For each of these facilities, FDA did not conduct an on-site inspection of the facility prior to issuing the warning letter. By McKenzie E.

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FDA Compounding 52

Drug Topics

MARCH 27, 2024

The agency issued warning letters to 6 companies manufacturing these products.

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FDA 201

BioPharm

JULY 1, 2023

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

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FDA 40

The FDA Law Blog

SEPTEMBER 6, 2023

“Commits” is probably not the right word, although it is a term repeated frequently in the Guidance, since the Guidance at this point is only a draft, and, like other FDA guidances, it states in a highlighted warning that it “does not establish any rights for any person and is not binding on FDA or the public.”

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FDA Packaging Documentation Labelling 45

The FDA Law Blog

AUGUST 14, 2023

One inspection resulted in FDA’s securing a consent decree to restrict or shut down operations, and two resulted in an “untitled letter,” which is not available to the public on FDA’s website. OAI is FDA’s classification for facilities it deems to be in an unacceptable state of compliance.

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FDA Dosage Compounding 52

Fierce Pharma

JANUARY 24, 2024

The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. | The FDA’s letter demanding a labeling change for Gilead Sciences’ Tecartus temporarily went missing on the agency’s website Tuesday. Instead, it's adjusted the wording of a proposed boxed warning.

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FDA Labelling 114

STAT

JANUARY 22, 2024

In June, the Food and Drug Administration issued a warning letter about advertisements for the drug Recorlev for Cushing’s syndrome — its first in more than a year about webpages that make “false or misleading claims” about prescription drugs.

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FDA 144

Drug Topics

AUGUST 31, 2023

The FDA issues warning letters to 3 infant formula manufacturers for violations, and officials with the Department of Health and Human Services recommend reclassifying marijuana as a schedule III drug.

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FDA 98

Drug Topics

SEPTEMBER 14, 2023

FDA sends warning letters to 8 companies over unapproved eye drops, healthcare visits delivered by nurse practitioners and physician assistants continue to increase, and WHO agrees on the first-ever patient safety rights charter.

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FDA 98

STAT

JANUARY 18, 2024

In a series of letters sent on Thursday, Sen. demanded the companies explain why they have, so far, not responded to warnings issued two months ago by the Federal Trade Commission to remove more than 100 patents from the registry. Amid a push to crack down on patent abuse by the pharmaceutical industry, a key U.S.

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Fierce Pharma

SEPTEMBER 20, 2023

After a manufacturing-related complete response letter held up the U.S. | But now the company warned a decision will likely be delayed past the third quarter. UCB had previously expected an FDA decision during the first half of the year after suffering a prior rejection on its medicine.

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FDA 121

Fierce Healthcare

JANUARY 3, 2024

However, new enforcement in effect with the New Year could see noncompliant hospitals' warnings letters issued to the public.

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Hospitals 130

Drug Topics

AUGUST 14, 2023

The act is currently set to go into effect in just over three months.

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FDA 98

STAT

OCTOBER 16, 2023

The FDA published a warning letter on Wednesday telling the company it should have submitted its software for approval before putting it on the market. The letter comes a year after the Food and Drug Administration announced its intention to regulate more health software tools, sending the industry into an uproar.

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FDA 137

Fierce Healthcare

JULY 21, 2023

Federal regulators are warning hospital systems and telehealth providers about the data privacy risks of using third-party tracking technologies.

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Hospitals 98

STAT

MAY 3, 2023

WASHINGTON – The tobacco giant RJ Reynolds is threatening to sue small vape shops if they do not stop selling flavored vapes, according to two letters obtained by STAT. The letters, both of which were sent in March, give the vape shops just a few days to confirm they will no longer sell flavored tobacco products.

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FDA 101

BioPharm

MAY 18, 2023

The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.

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FDA 52

STAT

JUNE 27, 2023

Food and Drug Administration warned the wholesaler for failing to ensure that “suspect” medicines did not enter the marketplace. In a June 8 letter, the agency rebuked Safe Chain Solutions for violating a federal law designed to bolster the integrity of the pharmaceutical supply chain.

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FDA 102

STAT

FEBRUARY 15, 2024

The regulator this week posted warning letters that it sent to two websites, Synthetix Inc. DBA Helix Chemical Supply and US Chem Labs.

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FDA 135

The FDA Law Blog

JANUARY 22, 2024

OC also has input into FDA’s more forceful enforcement measures, like warning letters, import alerts, and consent decrees. Recalls, warning letters to online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year.

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Compounding FDA Communication 59

Pharmaceutical Technology

FEBRUARY 14, 2024

The FDA has issued warning letters to two online sellers for selling unapproved versions of semaglutide and tirzepatide.

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FDA 59

The FDA Law Blog

AUGUST 16, 2023

He talked about regulatory discretion being exercised for drug manufacturing facilities with serious compliance problems, about how firms should respond to FDA inspectional observations, and about an upcoming guidance that will be of interest to generic drug manufacturing firms that have received Warning Letters.

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Documentation FDA 97

BioPharm

JANUARY 1, 2024

Reviewing regulatory documents, such as 483 forms and Warning Letters, can aid in determining a facility’s inspection readiness, says Siegfried Schmitt, vice president, Technical at Parexel.

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Documentation 52

STAT

JUNE 22, 2023

The FDA recently issued 189 formal warning letters to shops selling two brands of vape products, Elf Bar and Esco Bars, the agency announced in a press release Thursday. The FDA has not authorized either brand, both of which are ubiquitous in gas stations and smoke shops around the country.

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FDA 110

STAT

AUGUST 1, 2023

These serious violations of manufacturing protocols were revealed in a July 28 warning letter sent by the U.S. Some details were previously disclosed in an FDA inspection report made public, but the letter provides added information and context about agency concerns.

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Chemotherapy Documentation FDA 98

STAT

JULY 19, 2023

Chinese and Indian manufacturers receive the largest number of warning letters about quality control issues from the FDA, including carcinogens in medicines, destroyed or falsified data, and sterility problems in manufacturing.

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FDA 98

STAT

AUGUST 16, 2023

In a July 19 letter , the FDA warned Light Sciences Oncology about its failure to post study results about a prostate treatment to the database, ClinicalTrials.gov. After receiving the FDA letter, Light Sciences posted results on Aug. 2, although outstanding issues remain with its submission.

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FDA 97

The Checkup by Singlecare

MARCH 8, 2024

The biosimilars are also called adalimumab, but they have a four-letter suffix after the name. These letters are used to differentiate biosimilars from the original reference product. For example, if Teva makes a biosimilar, the last four letters cannot be -teva. This is not a full list of warnings.

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Dosage Pharmaceutical Companies Pharmaceutical Companies FDA 97

STAT

JANUARY 12, 2023

Every few months, we’re warned that the Omicron variant of the SARS-CoV-2 virus has spawned yet another subvariant, this one even more transmissible than the ones it is fast overtaking. The new entity is given a name, an unwieldy string of letters and numbers separated by periods. It’s like clockwork now.

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STAT

NOVEMBER 18, 2022

A FDA official says that most warning letters issued for manufacturing issues in fiscal year 2022 were the result of onsite inspections, reversing a pandemic-era trend of enforcement actions triggered by the use of alternative tools , according to Regulatory Focus. But the agency still faces a backlog.

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FDA Documentation Compounding Pharmaceutical Companies 95

STAT

JANUARY 10, 2023

Food and Drug Administration for a host of serious manufacturing violations at a key plant in India, the latest instance in which the company was tagged by the regulator for quality-control problems.

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FDA 100

Pharmaceutical Commerce

AUGUST 17, 2023

The act is currently set to go into effect in just over three months.

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FDA 52