European Pharmaceutical Review

MAY 9, 2024

Regulatory agencies in the US across three sectors: agriculture and environmental, have produced a joint plan to “update, streamline, and clarify” regulations and oversight mechanisms for biotechnology products. For instance, identifying what regulations or guidance needs amendment or the potential need for new such policies or rules.

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Communication 67

PharmaTech

MAY 9, 2024

Purna Thakker, founder and CEO of ADPT Solution, discusses common issues that companies face with FDA regulations at CPHI North America.

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STAT

OCTOBER 12, 2022

— Biotech companies developing cutting-edge cell and gene therapies often are tripped up by how much regulations around these drugs vary from country to country. On Wednesday, regulators from the United States, the European Union, and Japan came together to discuss the scale of the problem — and possible solutions.

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Drug Development 243

STAT

NOVEMBER 2, 2022

… An FDA advisory panel says it’s time for the agency to improve how it regulates pulse oximeters, STAT explains. The advisory panel urged the FDA to more rigorously test these devices and to issue warning labels that acknowledge the issue. Continue to STAT+ to read the full story…

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Labelling 215

Pharma Marketing Network

JULY 26, 2023

The Food and Drug Administration (FDA) plays a critical role in regulating the pharmaceutical industry and ensuring that medications and medical devices marketed to the public are safe, effective, and appropriately labeled. However, in recent years, there has been a noticeable decline in the number of these letters being issued.

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Pharmaceutical Companies Pharmaceutical Companies Labelling Drug Development 97

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. Our flavor today is glazed doughnut — sweets for the sweet, you know?

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Documentation 293

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.

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Documentation 133

FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). However, in our experience, there is a large gap between FDA’s lauding the value of RWE and practice. Congress has recognized the challenges with FDA’s acceptance of RWD and RWE.

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Medical Records Documentation 111

FDA Law Blog: Biosimilars

JANUARY 8, 2024

Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. We won’t repeat ourselves, but we will summarize—regulatory due diligence and an understanding of historical regulatory compliance issues is a critical component of assessing whether a deal is what it seems to be.

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FDA Law Blog: Biosimilars

MARCH 3, 2024

Mullen — FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards being finalized – and to a likely judicial showdown. This stands in marked contrast to FDA’s prior efforts to regulate LDTs (see posts here , here , and here ). By Jeffrey N. Gibbs & Allyson B.

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Express Pharma

APRIL 1, 2024

In a letter dated March 21, the US FDA India office country director Sarah McMullen said that four states (Gujarat, Telangana, Goa and Karnataka) had been ‘sensitised to FDA’s inspection process and, as such, are eligible for inclusion as observers for relevant inspection in their respective states.’

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FDA Law Blog: Biosimilars

MARCH 21, 2024

As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.

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Packaging Communication 64

FDA Law Blog: Biosimilars

MARCH 31, 2024

Gibbs — On March 21, 2024, the House Energy and Commerce held a subcommittee hearing titled “Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule.” FDA, which was not invited to participate, would surely have concurred. The FDA proposed rule elicited some strong criticism.

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Hospitals 64

FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

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Controlled Substances 64

European Pharmaceutical Review

MARCH 5, 2024

The US Food and Drug Administration (FDA) recently highlighted data integrity issues concerning premarket submissions received for medical devices. Consequently, because “it calls into question the data integrity of the entire file”, FDA asserted that is unable to rely on the data to grant marketing authorisation.

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Communication 79

FDA Law Blog: Biosimilars

MARCH 11, 2024

Lenz, Principal Medical Device Regulation Expert & Allyson B. Mullen — On February 20, 2024, FDA issued a letter to the medical device industry ( link ) warning medical device firms of recent FDA concerns related to fraudulent and unreliable laboratory testing data in premarket submissions. By Adrienne R.

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Communication 64

Pharma in Brief

JANUARY 7, 2024

On January 5, 2024, the US Food and Drug Administration ( FDA ) approved Florida’s proposal to import prescription drugs from Canada. This is the first approval of a Section 804 Importation Program ( SIP ) by the FDA. On January 5, 2024, the FDA issued a letter to Florida and a news release advising that the proposal was approved.

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FDA Law Blog: Biosimilars

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance.

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Documentation 105

FDA Law Blog: Biosimilars

FEBRUARY 19, 2024

Loloei is a 14-year veteran of the FDA, where most recently she served as a Senior Regulatory Counsel in the Office of Policy at CDRH. While at FDA, Ms. During her FDA tenure, Ms. It was a true honor and privilege to collaborate with so many fantastic coworkers and partners for nearly 14 incredible years at FDA.

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Labelling 59

Express Pharma

MARCH 26, 2024

The regulators have, in such cases, probed multiple issues like poor quality of certain medicines, Income Tax irregularities, money laundering. I presume, you took this ethical route to solve such issues in your companies. There are also allegations of allowing ineffective drugs to be authorized during the crippling pandemic.

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Pharmaceutical Companies Pharmaceutical Companies Hospitals 143

pharmaphorum

SEPTEMBER 29, 2022

The FDA’s General Approach to Regulating mHealth Products. Food and Drug Administration (FDA) regulation as a medical device. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’.

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Documentation 99

Pharmaceutical Business Review

SEPTEMBER 11, 2023

As per the new guidance, the regulator has agreed with Citius’ plans to meet the conditions provided in a complete response letter (CRL) issued on 28 July 2023. For the planned resubmission anticipated to occur in early 2024, the FDA has sought no further clinical efficacy or safety trials.

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European Pharmaceutical Review

JANUARY 29, 2024

N-Nitrosamines By far the biggest issue bedevilling industry during 2023 was the continuing N-nitrosamine contamination saga, which was covered in the third issue of EPR 2023. In contrast, NDSRIs (N-Nitrosamine drug substance-related impurities) are still a burgeoning issue with many new NDSRIs being reported on a weekly basis.

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Drug Development Vaccines Compounding 94

FDA Law Blog: Biosimilars

MARCH 6, 2024

John counsels FDA-regulated entities on litigation, enforcement, and compliance matters including FDA inspections, Form 483s, Warning and Untitled Letters and Consent Decrees, internal investigations, and data privacy concerns. FDA Law Blog readers can use discount code S10-866-866L24.S S for reduced registration fees.

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FDA Law Blog: Biosimilars

OCTOBER 5, 2023

Walsh — DOJ has issued another “voluntary disclosure” policy intended to encourage companies to disclose misconduct it discovers as part of a merger and acquisition. But it is intended to apply DOJ-wide, meaning it applies to FDA criminal violations prosecuted by DOJ’s Consumer Protection Branch (CPB).

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LifeProNow

APRIL 6, 2023

FDA announced it is requiring manufacturers of opioid analgesics dispensed in outpatient settings to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. April 03, 2023: “The U.S. Califf, M.D. “We Postal Service.”

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Quality Matters

MARCH 8, 2024

Consumer awareness and industry regulation According to top-line data from a 2023 Council for Responsible Nutrition (CRN) report, 74% of U.S. 2 Unfortunately, most consumers don't have a strong understanding of how the dietary supplement industry is regulated, which can result in confusion about the role of regulatory agencies – like the U.S.

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Labelling 98

FDA Law Blog: Biosimilars

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation. Javitt — On Monday, Hyman, Phelps & McNamara, P.C.

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FDA Law Blog: Biosimilars

MAY 3, 2023

Livornese — FDA posted the last five “deemed final orders” under OTC monograph reform this week. All 33 of the final orders can now be found at OTCMONOGRAPHS@FDA. the regulations formerly found in 21 C.F.R. By Deborah L. parts 331 through 358) were deemed to be final administrative orders as of the CARES Act effective date.

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FDA Law Blog: Biosimilars

APRIL 30, 2024

Baumhardt, Senior Medical Device Regulation Expert — FDA recently issued a draft guidance on Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program , which included some changes over the existing guidance which could have a negative impact on future pre-submissions.

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Communication 64

FDA Law Blog: Biosimilars

APRIL 25, 2024

Promotional labeling is generally any labeling other than FDA-required labeling that is devised for the promotion of a product, as well as other functions, and can include printed, audio, or visual matter that describes the product. l)(1) (e.g.,

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Biosimilars Labelling Communication 59

Pharmaceutical Technology

FEBRUARY 2, 2023

If things go as per plan, in a few months, the US Food and Drug Administration (FDA) will deliberate on the first-of-its-kind CRISPR-based gene therapy for sickle cell disease (SCD) and transfusion-dependent beta thalassemia. You can also subscribe here to receive email notifications when a new issue is available.

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FDA Law Blog: Biosimilars

JANUARY 1, 2024

Maybe that’s also why FDA last week publicized the highest number of important Warning Letters of the year (compared with prior releases in 2023). Perhaps FDA wanted us to remember 2023 as the year FDA succeeded in uncovering critical defects in drug and device manufacturing, and in critical trials. Dextrum Laboratories Inc.

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Documentation Labelling 59

FDA Law Blog: Biosimilars

JANUARY 18, 2024

Palmer — A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). District Court challenging FDA’s plan to remove their products from the market. Specifically, FDA is looking to remove a drug called carbadox from the market. By John W.M.

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Communication 59

FDA Law Blog: Biosimilars

JUNE 19, 2023

Cato — The long-running saga of FDA regulation of laboratory-developed tests (LDTs) has taken yet another new turn. Take for example FDA’s Unified Agenda announcement for ISO 13485 harmonization, which first occurred in the Spring of 2018 and was re-issued until a proposed rule was published in early 2022 (see our post here ).

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Documentation 56

FDA Law Blog: Biosimilars

OCTOBER 16, 2023

Three of these articles focus on medical applications of Artificial Intelligence and Machine Learning (AI/ML) and explore FDA’s role in regulating such products. Meanwhile, FDA’s AI/ML-focused initiatives continue to expand. The first article—“Is the Eye the Window to Alzheimer’s?”—discusses

Documentation 119

Documentation 119

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. Prior notice” informs FDA about the products it can expect to be offered for import into the country. By Sophia R. food supply and other food-related emergencies.

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