The FDA Law Blog

NOVEMBER 29, 2023

Since that time, FDA issued a draft guidance for predetermined change control plans (PCCPs) for Artificial Intelligence/Machine Learning (AI/ML) software functions. FDA considers these guiding principles as complimentary to their recent efforts around PCCPs including their proposed draft guidance on PCCPs.

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Pharmaceutical Technology

JUNE 13, 2023

The US Food and Drug Administration (FDA) approved Ferring Pharmaceuticals’ Prior-Approval Supplement (PAS) to the Biologics License Application (BLA) for the bladder cancer gene-therapy Adstiladrin (nadofaragene firadenovec). 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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FDA Vaccines Chemotherapy Communication 98

pharmaphorum

JULY 11, 2021

In another twist to the Aduhelm approval tale, FDA’s Janet Woodcock has called for an independent investigation into the relationship between agency staffers and Biogen executives. In the letter, she writes: “FDA’s decisions are far ranging and it is inevitable that some of those decisions will lead to controversy.”

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Pharmaceutical Technology

JULY 20, 2022

On 6 July, in an effort to accelerate access, the US Food and Drug Administration (FDA) allowed pharmacists to also begin prescribing the drug to eligible individuals with Covid-19. In its announcement, the FDA advised individuals to keep their electronic or printed health records from the past year ready while seeking treatment.

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Digital Pharmacist

NOVEMBER 21, 2022

Food and Drug Administration (FDA) announced its approval of the Boostrix vaccine, commonly known as Tdap (combination of Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis) for immunization administration during the third trimester of pregnancy to prevent pertussis in infants younger than two months of age.

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Pharmaceutical Technology

MAY 12, 2023

As the next step in the FDA’s efforts to reduce prescription drug deaths , the agency is requiring updates to the boxed warning and other information for attention deficit hyperactivity disorder (ADHD) prescription stimulants. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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Labelling FDA Communication 59

pharmaphorum

APRIL 13, 2022

J&J and two Ethicon subsidiaries were held by the earlier ruling to have wilfully circulated misleading medical device instructions and marketing communications which “misstated, minimised, and/or omitted the health risks of Ethicon’s…pelvic mesh products.”

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Communication FDA 59

Pharmaceutical Technology

MAY 4, 2023

After a winter marked by a rise in hospitalisations due to the RSV, the FDA has granted its first approval for an Respiratory Syncytial Virus (RSV) vaccine to GSK’s Arexvy for adults ages 60 years and above. These recommendations and the FDA approval were based on positive AReSVi-006 Phase III trial data.

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Vaccines FDA Communication Immunization 64

Pharmaceutical Technology

MAY 3, 2023

Since 2015, the US Food and Drug Administration (FDA) has approved more than 450 “first generics” or the first generic equivalent for a branded drug. In its 2022 annual report on generics, the US FDA stated it had approved 106 first generics, which it claimed would offer significant cost savings for patients. from 2001 to 2022.”

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FDA Generic Medicine Communication 98

Pharmaceutical Technology

JUNE 21, 2023

This is the first time the FDA has approved an oral diabetes drug for paediatric patients since its approval of metformin in 2000. The FDA first approved Jardiance to help control blood sugar in adults with T2D in 2014. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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FDA Communication 59

Pharmaceutical Technology

MAY 31, 2023

The US Food and Drug Administration (FDA) has proposed a new model for prescription medication guides for brand name and generic drugs, to increase accessibility and reduce medication nonadherence. The FDA said that the proposed revamp should help limit preventable adverse drug reactions and improve health outcomes.

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Pharmaceutical Technology

MARCH 6, 2023

Currently, most drugs being investigated for their healthy aging or anti-aging properties are being repurposed from readily accessible FDA-approved drugs. Barzilai hopes that the well-established profile of the drug may allow the FDA to accept the trial more easily and then other aging-related studies can follow.

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Pharmaceutical Technology

MAY 24, 2023

Innoviva has snagged a win for its bacterial pneumonia drug Xacduro (durlobactam sodium + sulbactam) with a US Food and Drug Administration FDA approval for use in patients of ages 18 or older. The FDA approval stemmed from results from Entasis’ Phase III Attack trial (NCT03894046). Please check your email to download the Report.

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FDA Communication Hospitals 52

Pharmaceutical Technology

MAY 23, 2023

The US Food and Drug Administration (FDA) has granted Centessa Pharmaceuticals’ activated Protein C (APC) inhibitor SerpinPC a fast track designation for treating haemophilia B. The FDA’s fast track designation is designed to speed up the regulatory process to allow faster drug development and review to fill unmet needs.

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The FDA Law Blog

AUGUST 21, 2023

Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts. Interestingly, the Plaintiffs alleged that this duty existed when the mother was pregnant in 2015 even though the studies relied upon in the litigation are from 2021.

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Labelling FDA Vaccines Communication 40

Pharmaceutical Technology

JUNE 20, 2023

UK-based biotech F2G was dealt a blow as the US’ FDA issued a complete response letter rejecting its latest new drug application (NDA). F2G claimed in a June statement that the FDA requested additional data and analysis that extended beyond the current review period. Free Report How is the Biopharmaceutical industry evolving?

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FDA Packaging Communication Labelling 52

The People's Pharmacy

APRIL 13, 2023

FDA Considers New Warnings on LASIK Eye Surgery: The FDA first approved the laser devices for this procedure in 1999. Consequently, he petitioned the FDA to issue a Public Health Advisory regarding LASIK-related injuries. The FDA understands LASIK is safe and effective for those who are good candidates.

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FDA Communication 81

Pharmaceutical Technology

APRIL 6, 2023

The US Food and Drug Administration (FDA) has released the fourth and final chapter in a series of guidance documents designed to support patient-focused drug development. The guidance also touched upon clinical trial design elements that must be explained, described, or rationalised to the FDA.

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FDA Documentation Communication 52

The FDA Law Blog

DECEMBER 7, 2023

In his conference keynote address , Arun Rao—the Deputy Assistant Attorney General for DOJ’s Consumer Protection Branch—provided an overview of DOJ’s year in FDA enforcement. We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing.

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FDA Communication 52

BuzzRx

OCTOBER 31, 2022

In July 2021, the pharmaceutical company Pfizer issued a voluntary nationwide recall of Chantix (varenicline) tablets as a precautionary measure; this is due to the evidence of higher levels of nitrosamines in Chantix than what’s considered acceptable by the U.S. FDA guidelines. In May 2022, the FDA said it is now confident in U.S.

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Pharmaceutical Technology

APRIL 6, 2023

Verismo Therapeutics has received fast track designation from the US Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110. Verismo Therapeutics CEO, DMD and co-founder Dr Bryan Kim said: “We are thrilled to receive Fast Track designation from the FDA. Please check your email to download the Whitepaper.

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FDA Communication 52

The Checkup by Singlecare

JANUARY 23, 2024

Some would question whether any individuals should take black seed oil since it has not been sufficiently tested with peer-reviewed, placebo-controlled studies and is not approved for use by the Food and Drug Administration (FDA). Before and during the use of any supplement, communication with your care providers is key.

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Adverse Reactions Communication FDA 102

Pharmaceutical Technology

MAY 15, 2023

If approved, the therapy could become the first FDA-approved gene transfer therapy for the condition. The FDA will assess the drug’s approval before its Prescription Drug User Fee Act (PDUFA) date on 29 May 2023. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.

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FDA Hospitals Communication 52

The FDA Law Blog

AUGUST 16, 2023

The last Warning Letter OPDP issued was in early 2022 to CytoDyn for promoting its investigational drug as an effective treatment for COVID-19 despite a failed study (and despite an FDA release issued a year prior about the same failed study – but that’s another story ). Therefore, the presentation of these claims (i.e., What does this mean

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The Checkup by Singlecare

FEBRUARY 1, 2024

Food and Drug Administration (FDA) to treat opioid use disorder and alcohol use disorder. Communicating openly with your healthcare team about all medical conditions you have and medications you take is the best way to identify potential naltrexone interactions. It comes as an oral tablet and intramuscular (IM) injection.

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Communication Dosage FDA 92

Pharmaceutical Technology

MAY 9, 2023

New York-based Eyenovia has announced an FDA approval for Mydcombi (tropicamide and phenylephrine hydrochloride), the first ophthalmic spray for mydriasis or pupil dilation. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving?

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FDA Communication 52

The FDA Law Blog

NOVEMBER 2, 2023

Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Tobolowsky & Richard A. It finalized a draft guidance published in 2022.

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FDA Packaging Documentation Communication 59

Pharmaceutical Technology

MAY 31, 2023

In January 2021, the US Food and Drug Administration (FDA) granted SNIPR001 a fast track designation. Several CRISPR-based gene therapies are in development , with one for sickle cell disease and transfusion-dependent beta thalassemia (TDT), being examined by the FDA for an approval.

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Chemotherapy FDA Communication Immunization 98

Pharmaceutical Technology

JUNE 16, 2023

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. Promising results were observed, with outcomes of 19.0% ORR, 81.0%

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Pharmaceutical Technology

MAY 3, 2023

The US Food and Drug Administration (FDA) has granted Tenaya Therapeutics’ gene therapy TN-201 a fast track designation for the treatment of myosin binding protein C3 (MYBPC3)-associated hypertrophic cardiomyopathy (HCM). In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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Pharmaceutical Technology

JANUARY 6, 2023

Last year, Novartis began with a win in January, as the US Court of Appeals affirmed the validity of Gilenya’s patent, allowing the company to sue a competitor generics company for filing for FDA approval for its Gilenya generic. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. 10,633,344.

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Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. compared to a 5.1% Free Report.

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Labelling Insurance Communication FDA 105

Pharmaceutical Technology

APRIL 18, 2023

This news follows the treatment’s FDA approval on 10 March, making it the first-approved Rett Syndrome treatment in the US. The FDA approved the drug based on positive Phase III data from the Lavender trial. We have worked hard to make Daybue available as quickly as possible following FDA approval.”

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FDA Communication 102

pharmaphorum

AUGUST 26, 2021

As well as this, government bodies are also becoming more interested in incorporating the patient voice in the regulatory process, with both the FDA and EMA having patient-focused programs and committees. As momentum builds in this area, we are delighted to be involved with the first-ever annual Patient Engagement Day on 1 September 2021.

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Pharmaceutical Technology

APRIL 12, 2023

In 2021, they accounted for 0.2% However, according to the US Food and Drug Administration (FDA), non-human primates are still the most scientifically relevant large model to test biologic drugs for safety. The ABPI points to the FDA in the US as an example. The FDA’s Modernization Act 2.0

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Pharmaceutical Technology

NOVEMBER 30, 2022

In October, the US FDA granted Eli Lilly’s Mounjaro (tirzepatide) a Fast Track designation for its use as a treatment for obesity. The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. compared to a 5.1% Free Report.

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Labelling Insurance Communication FDA 98

The Checkup by Singlecare

NOVEMBER 9, 2023

Sources Acute sinusitis , Medscape (2023) Sinus infections , Penn Medicine (2022) Sinus infections , Centers for Disease Prevention and Control (2019) Nasal irrigation to treat acute bacterial rhinosinusitis , American Family Physician (2005) How to perform nasal irrigation , UpToDate (2023) Is Rinsing Your Sinuses With Neti Pots Safe? ,

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