Pharma Rep Focus

FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

Fierce Pharma

APRIL 10, 2024

In a four-observation warning letter issued this week, the U.S. It usually goes without saying that your pharmaceutical production workers need to be gowned and gloved while handling drug materials inside clean rooms. |

FDA

FDA Manufacturing Pharmaceutical products Healthcare

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic

Fierce Pharma

FEBRUARY 14, 2024

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic fkansteiner Wed, 02/14/2024 - 05:10

Manufacturing

Manufacturing Sales FDA

In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

Fierce Pharma

SEPTEMBER 12, 2023

Eight companies are finding themselves in hot water for allegedly churning out illicit eye drugs, the FDA said Tuesday. | The companies included in the warning letter sweep are: Boiron, CVS Health, DR Vitamin Solutions, Natural Ophthalmics, OcluMed, Similasan, TRP Company and Walgreens Boots Alliance.

FDA

Intas analyst poured acid over manufacturing docs, FDA says in scathing warning letter

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.

Manufacturing

Manufacturing FDA Pharmaceutical

FDA warning letters highlight data integrity issues

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

FDA Food and Drug Administration Manufacturing Pharmaceutical manufacturing

FDA warning letters highlight CAPA concerns

European Pharmaceutical Review

AUGUST 10, 2023

Amidst numerous warning letters distributed by the US Food and Drug Administration (FDA) to pharmaceutical manufacturers in recent months, in July this year, the US regulatory body published its analysis on drug product quality in 2022. Eight FDA warning letters were handed to European companies in 2018.

FDA

FDA Food and Drug Administration Media Manufacturing

FDA Warning Letter Issued to Website Purveying Ivermectin Pills for Covid-19

MedCity News

MARCH 21, 2023

The FDA has issued a warning letter to a website that has been selling the antiparasitic drug ivermectin as a treatment for Covid-19. The correspondence directs the company to stop selling its products and correct any misleading language in its marketing material.

FDA

FDA Marketing Biopharma Pharma

Common pharma compliance concerns cited by FDA warning letters

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

FDA Food and Drug Administration Pharma Pharmaceutical manufacturing

FDA warning letter puts maker of nicotine gummies in a sticky situation

MedCity News

AUGUST 21, 2022

The FDA issued a warning letter about nicotine gummies—the first ever notification sent for such a product. The agency’s concern is that the flavored gummies resemble candy and pose a toxicity risk to children.

FDA

FDA Biopharma Pharma

FDA Issues Warning Letter to Amazon Over Sale of Unapproved Ophthalmic Products

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.

Sales

Sales FDA

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

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.

Safety

Safety FDA

FDA Issues Warning Letter to AstraZeneca Regarding Breztri Aerosphere Promotional Communication

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.

FDA

FDA issues Cipla warning letter after thousands of complaints

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.

FDA

The Inspection Result: Warning Letters and Form 483s

PharmaTech

JULY 2, 2023

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

FDA

FDA Issues Warning Letter on Nyquil

Pharma Leaders

MARCH 22, 2023

In a March 14 warning letter to the company, the agency threatened that a failure to adequately address the matter “may result in legal action,” including the possibility of seizure and injunction.

FDA

FDA Electronics

UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

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.

Manufacturing

Manufacturing FDA Medicine

Are You Ready for Inspection?

PharmaTech

JANUARY 2, 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.

FDA Sends Warning Letter to Arizona Facility

PharmaTech

MAY 18, 2023

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

FDA

FDA cracks down on online retailers selling unapproved GLP-1 agonists

Pharmaceutical Technology

FEBRUARY 14, 2024

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

Retail

Retail FDA

Court Rules FDA Must Divulge Internal Deliberations on Vanda’s Hetlioz sNDA

Pharma Leaders

MARCH 30, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Pharmaceutical Marketing

FDA Considers Biomarker Data Supportive of Tofersen Approval

Pharma Leaders

MARCH 21, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Pharmaceutical Marketing

CDER Flags Enforcement Successes for Fiscal 2022

Pharma Leaders

MARCH 20, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Pharmaceutical Marketing

US Representatives From Ohio, New Hampshire Write Bipartisan Letter to FDA Warning of Potential DSCSA Problems

Pharmaceutical Commerce

AUGUST 17, 2023

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

FDA

Write it Down, Investigate, and Control

PharmaTech

JANUARY 2, 2023

FDA sent a variety of warning letters to drug manufacturers at the end of 2022 highlighting myriad CGMP and quality control violations.

Manufacturing

Manufacturing FDA

What can we learn from contamination control failures?

European Pharmaceutical Review

JULY 7, 2022

Inadequate investigations and failure to follow standard operating procedures (SOPs) are some of the most common causes for regulatory warning letters in companies, according to Jeanne Moldenhauer, Vice President of Excellent Pharma Consulting.

Training

Training Manufacturing FDA Consulting

Ensuring adequate sanitisation: disinfectant-resistant microbes in cleanrooms

European Pharmaceutical Review

JULY 12, 2022

More than 480 warning letters solely related to the failure to produce aseptic conditions because of deficient cleaning and disinfection systems for cleanrooms and their equipment, were issued by regulators between 2013 to 2018. The authors reported moderate and high growth of plasmid-transformed E.

Pharmaceutical manufacturing

Pharmaceutical manufacturing Pharmaceutical Pharmaceutical research Manufacturing

The criticality of compliance

pharmaphorum

OCTOBER 12, 2022

However, as necessary as data is, it has ironically been sighted as one of the top concerns related to the issuing of observation notices and warning letters by regulators. In fact, the FDA cited data as the cause of 79% of Drug Warning Letters over the last five years.

Manufacturing

Manufacturing Medicine Leads Distribution

Warning Letters Trend Toward Component Testing, Contractor Oversight in 2022

Pharma Leaders

APRIL 18, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

pharmaphorum

JULY 28, 2022

Fritz has successfully managed, resolved and consulted on large complex compliance projects including corporate warning letters, mass seizure, consent decree(s), Application Integrity Policy (AIP) prosecution and import detentions.

Pharma

Pharma Consulting FDA Manufacturing

Evaluating NMR relaxometry for antibody identification

European Pharmaceutical Review

SEPTEMBER 25, 2023

Failure to do so has resulted in several warning letters to manufactures. Identity testing of raw materials under GMP Good manufacturing practices (GMP) require that materials received for manufacture be tested to confirm identity (eg, 21 CFR 211.84, EU GMP Annex 8). IPQ International Pharmaceutical Quality. Cited 2023Feb].

Pharmaceutical

Pharmaceutical Manufacturing Food Electronics

What can Rishi Sunak do for the UK’s pharma industry

Pharmaceutical Technology

NOVEMBER 4, 2022

In June, the Association of the British Pharmaceutical Industry (ABPI) sent an open letter to the Conservative leadership, including Truss and Sunak, which warned that the UK is slipping behind its global competitors in the race to become a life sciences superpower.

Pharma

Pharma Government Pharmaceutical Medicine

FDA releases analysis on drug product quality in 2022

European Pharmaceutical Review

JULY 3, 2023

Reflecting on five years of quality control for nitrosamine impurities Warning Letters In FY2022, the FDA issued 72 CGMP-related warning letters to pharmaceutical manufacturing sites. Most that received warning letters (68 percent) were FDF manufacturers of non-sterile, non-application products.

FDA

FDA Food and Drug Administration Manufacturing Product sample

Healthcare Watch September 2022

PM360

SEPTEMBER 15, 2022

Another 80% of consumers said that they are at least somewhat unlikely to use a specific healthcare product if they learn the FDA has issued a warning letter related to product quality issues. adults are unlikely to use a prescription drug that has experienced a recall, regardless of whether that issue was fixed.

Healthcare

Healthcare Healthcare Doctors Physicians

Use Quantitative Information for Consumer-Facing Promotion, FDA Guidance Says

Pharma Leaders

JUNE 27, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

FTC Slams District Court Decision, Supports Pharmacies in Bystolic Antitrust Case

Pharma Leaders

JUNE 22, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

CBER, CDER Directors Review Priorities and Challenges at FDLI Annual Conference

Pharma Leaders

MAY 19, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

Califf: Diabetes, Weight Loss, Alzheimer’s Drugs Could Be “Major Game Changers”

Pharma Leaders

MAY 17, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

FDA Seeks Feedback on AI and Machine Learning in Drug Development

Pharma Leaders

MAY 12, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

Senate HELP Committee Votes to Send Four Drug Reform Bills to Full Chamber

Pharma Leaders

MAY 11, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

FDA Final Guidance on Glycerin, High-Risk Drug Components Aims to Prevent Poisonings

Pharma Leaders

MAY 9, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

MDSAP QMS Implementation Plan Highlights Ongoing Assessments and Improvements

Pharma Leaders

MAY 8, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

FDA Final Guidance Details PDUFA VII Fee Program, Assessment Changes

Pharma Leaders

MAY 5, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

Number of Overdue Priority Review ANDAs Dips in FY 2023

Pharma Leaders

MAY 3, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

FDA Issues Final Guidance on Nicotine Replacement Therapies

Pharma Leaders

MAY 1, 2023

You can count on Drug Industry Daily for insightful, accurate articles supported by links to additional key documents, such as FDA guidances and comments, warning letters, full texts of proposed legislation, Federal Register postings, GAO reports and more.

FDA

FDA Manufacturing Pharmaceutical Pharma

FDA lambasts Kilitch for unsanitary manufacturing conditions and issues warning letter to Natco, too

FDA unleashes multiple warning letters targeting insanitary manufacturing and online sales of unapproved Mounjaro, Ozempic

Trending Sources

In warning letters, FDA tells 8 companies to stop selling illicit eye drugs

Intas analyst poured acid over manufacturing docs, FDA says in scathing warning letter

FDA warning letters highlight data integrity issues

FDA warning letters highlight CAPA concerns

FDA Warning Letter Issued to Website Purveying Ivermectin Pills for Covid-19

Common pharma compliance concerns cited by FDA warning letters

FDA warning letter puts maker of nicotine gummies in a sticky situation

FDA Issues Warning Letter to Amazon Over Sale of Unapproved Ophthalmic Products

Gilead's Tecartus gets revised safety demand amid FDA's push for CAR-T boxed warnings

FDA Issues Warning Letter to AstraZeneca Regarding Breztri Aerosphere Promotional Communication

FDA issues Cipla warning letter after thousands of complaints

The Inspection Result: Warning Letters and Form 483s

FDA Issues Warning Letter on Nyquil

UCB's psoriasis drug application overcomes manufacturing hurdle but hits another FDA delay

Are You Ready for Inspection?

FDA Sends Warning Letter to Arizona Facility

FDA cracks down on online retailers selling unapproved GLP-1 agonists

Court Rules FDA Must Divulge Internal Deliberations on Vanda’s Hetlioz sNDA

FDA Considers Biomarker Data Supportive of Tofersen Approval

CDER Flags Enforcement Successes for Fiscal 2022

US Representatives From Ohio, New Hampshire Write Bipartisan Letter to FDA Warning of Potential DSCSA Problems

Write it Down, Investigate, and Control

What can we learn from contamination control failures?

Ensuring adequate sanitisation: disinfectant-resistant microbes in cleanrooms

The criticality of compliance

Warning Letters Trend Toward Component Testing, Contractor Oversight in 2022

How can the pharma industry navigate issues in the global supply chain to minimise drug shortages?

Evaluating NMR relaxometry for antibody identification

What can Rishi Sunak do for the UK’s pharma industry

FDA releases analysis on drug product quality in 2022

Healthcare Watch September 2022

Use Quantitative Information for Consumer-Facing Promotion, FDA Guidance Says

FTC Slams District Court Decision, Supports Pharmacies in Bystolic Antitrust Case

CBER, CDER Directors Review Priorities and Challenges at FDLI Annual Conference

Califf: Diabetes, Weight Loss, Alzheimer’s Drugs Could Be “Major Game Changers”

FDA Seeks Feedback on AI and Machine Learning in Drug Development

Senate HELP Committee Votes to Send Four Drug Reform Bills to Full Chamber

FDA Final Guidance on Glycerin, High-Risk Drug Components Aims to Prevent Poisonings

MDSAP QMS Implementation Plan Highlights Ongoing Assessments and Improvements

FDA Final Guidance Details PDUFA VII Fee Program, Assessment Changes

Number of Overdue Priority Review ANDAs Dips in FY 2023

FDA Issues Final Guidance on Nicotine Replacement Therapies

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