The FDA Law Blog

SEPTEMBER 19, 2023

Industry has long requested input from FDA about the types of patents that can be listed in the Orange Book, and, in response, FDA asked for comments on the types of patents that should be listed. But FDA has never made an affirmative statement as to the types of patents that can be listed in the Orange Book.

FDA 105

FDA Communication Dosage 105

pharmaphorum

AUGUST 10, 2020

Biogen’s Alzheimer’s drug aducanumab could be on the market in the next few months after the FDA accepted a clinical trial dossier and granted a fast Priority Review. The FDA reserves these quick reviews for drugs that have the potential to improve care standards for serious diseases.

FDA 104

FDA 104

Pharma Mirror

OCTOBER 4, 2021

Despite untold investment by numerous pharmaceutical companies, FDA-approved drugs that target critical brain functions and conditions like anxiety, depression, and sedation continue to present severe and unpredictable side effects, including suicidal ideation. In 2003 the Human Genome Project provided the first atlas.

Pharmaceutical Companies 119

Pharmaceutical Companies Pharmaceutical Companies FDA 119

pharmaphorum

JUNE 7, 2021

Biogen and Eisai have defied the naysayers and secured an historic FDA approval for their amyloid-targeting antibody aducanumab as the first-ever disease-modifying treatment for Alzheimer’s disease. The approval of aducanumab, now given the name Aduhelm, comes after a three-month extension to the FDA’s review period.

FDA 87

FDA 87

pharmaphorum

JUNE 8, 2021

The FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Biogen’s Alzheimer’s disease drug Aduhelm. The post FDA slammed over Aduhelm OK as Biogen takes heat for $56k price tag appeared first on.

FDA 98

FDA Labelling 98

Hospital Pharmacy Europe

APRIL 27, 2023

A 2003 study suggested that 5-alpha reductase inhibitors (5-ARIs) such as finasteride, prevent or delay the appearance of prostate cancer. However, the FDA warned in 2011 that 5-ARIs may increase the risk of a more serious form of prostate cancer. million new cases in 2020.

Hospitals 98

Hospitals FDA 98

The FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. And FDA still hasn’t said a thing! In fact, federal law and regulation appear to require AbbVie to list these patents.”

Dosage 59

Dosage FDA 59

The Checkup by Singlecare

APRIL 17, 2024

Food and Drug Administration (FDA) approved Wegovy for adults and children 12 years and older who have a body mass index (BMI) of 30 or higher or who have a BMI of 27 or higher with a related medical condition, such as high blood pressure, Type 2 diabetes, or high cholesterol.

Insurance 52

Insurance Insurance Coverage Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 27, 2022

Biogen and Eisai have increased the earning potential of their Alzheimer’s drug Aduhelm by expanding the post-marketing trial of the drug required by the FDA – which could be the primary source of income for the drug.

FDA 80

FDA Insurance Labelling 80

pharmaphorum

NOVEMBER 20, 2022

The FDA subsequently raised serious concerns about the accuracy of testing that Theranos did conduct with its machines, and the company eventually retracted two years of blood tests before folding in 2018. “She knew that it could not successfully compete with the established conventional machines.”

FDA 116

FDA 116

The Checkup by Singlecare

MARCH 7, 2024

Yet the Food and Drug Administration (FDA) hasn’t approved this GLP-1 agonist injection for weight loss. Instead, it’s FDA approved to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of adverse cardiovascular events in adults with Type 2 diabetes and known heart disease.

Compounding Pharmacies 93

Compounding Pharmacies Insurance Insurance Coverage Compounding 93

PharmaShots

APRIL 20, 2023

Food and Drug Administration (FDA) in June 2020 as a rapid-acting insulin to improve glycemic control in adults with type 1 and type 2 diabetes. On October 14, 2022, the FDA approved Lyumjev® (insulin lispro-aabc injection), a rapid-acting mealtime insulin, for the treatment of children with diabetes.

FDA 40

FDA Insurance Labelling 40

Pharmaceutical Technology

SEPTEMBER 23, 2022

Dry eye syndrome (DES) is an indication whose mainstay treatment has been dominated by Allergan’s Restasis (cyclosporine ophthalmic emulsion 0.05%) ever since its launch in 2003 in the US. Novaliq/ Bausch + Lomb’s NOV-3 (perfluorohexyloctane) is also currently at pre-registration stage with the FDA. Novaliq’s CyclASol (0.1%

FDA 59

FDA 59

pharmaphorum

NOVEMBER 4, 2020

As an influential panel of FDA-appointed experts prepares its verdict on Biogen’s Alzheimer’s drug, a little known China-based pharma is hoping to succeed where big name rivals have failed and develop a drug that is effective against the disease.

FDA 68

FDA 68

The Checkup by Singlecare

JANUARY 20, 2023

Food and Drug Administration (FDA), generic medications cost 80%-85% less than brand-name drugs. Chances are, you’ve taken a generic or authorized generic medication, and for good reason—according to the U.S. An estimated 90% of prescriptions filled in the United States are for commonly prescribed generic drugs.

Prescription Filling 98

Prescription Filling Dosage FDA Labelling 98

The Checkup by Singlecare

DECEMBER 15, 2023

Food and Drug Administration (FDA) when proper dosage is followed. Food and Drug Administration (2003) The post Does Zyrtec make you drowsy? How to use Zyrtec safely Zyrtec is considered safe by the U.S. Always follow the instructions on the label for accurate dosing. appeared first on The Checkup.

Pharmacy Program Director 116

Pharmacy Program Director Dosage Labelling FDA 116

pharmaphorum

MAY 24, 2022

Vaccines used during the smallpox eradication programme can provide around 85% protection against monkeypox, according to the WHO, which notes that one newer vaccine – Bavarian Nordic’s Jyneos – has been approved by the FDA for prevention against both viruses. The US FDA also approved a new intravenous form of the drug last week.

Vaccines 84

Vaccines Labelling FDA 84

The Checkup by Singlecare

APRIL 17, 2024

Legislation passed in 2003 prohibits Medicare from covering drugs prescribed specifically for weight loss, and while Medicaid has more flexibility here, not every state will cover them. I tried to prescribe Mounjaro, which helps with heart failure and diabetes, but I couldn’t get it covered.”

Insurance 52

Insurance Insurance Coverage Compounding Pharmacies Compounding 52

The Checkup by Singlecare

OCTOBER 20, 2023

In another small 2003 study where researchers placed participants into two groups—a placebo group and a shilajit receiving group—the researchers found a decrease in cholesterol and triglyceride levels in the shilajit group. Supplements are not regulated by the Food and Drug Administration (FDA), so contamination is possible.

Immunization 105

Immunization FDA 105

PharmaShots

APRIL 13, 2023

Through the inclusion of Pharmacia’s products along with a strong performance, Pfizer’s pharmaceutical and animal health revenue was boosted by 40% and 43% respectively In the year 2003, Johnson & Johnson generated a revenue of $41.9B which depicted a growth of 15.3% as compared to the previous year. from last year.

Vaccines 40

Vaccines Pharmaceutical Companies Pharmaceutical Companies Labelling 40

Pharmaceutical Technology

SEPTEMBER 22, 2022

AstraZeneca ’s cholesterol drug Crestor (rosuvastatin) was approved in 2003 in the US but only approved in Germany in 2008. In 2013, the FDA first approved Vazkepa solely for the reduction of triglyceride levels for hypertriglyceridemia. Following this, in 2019, the FDA approved Vazkepa for the reduction of cardiovascular risk.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies FDA Dosage 52

ISPE

SEPTEMBER 15, 2022

First published in 1989, there have been a total of 5 adaptations in 1996, 2003, 2005, 2007 and 2009, but no complete revision. Thomas Zimmer, PhD. 15 September 2022. Annex 1 of the EC GMP Guide " Manufacture of Sterile Medicinal Products " has a long history. 12 of February 2020 again received 2,000 comments from public consultation.

Documentation 97

Documentation FDA 97

pharmaphorum

JANUARY 4, 2022

Stanford University drop-out Holmes founded Theranos in 2003 when she was just 19, and at its height the company was worth $9 billion, with its founder feted as the next Steve Jobs. Theranos raised almost $1 billion from investors before the company and its claims were eventually exposed as a sham.

Documentation 52

Documentation Communication FDA 52

The Checkup by Singlecare

FEBRUARY 1, 2024

Food and Drug Administration (FDA) to treat opioid use disorder and alcohol use disorder. Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Naltrexone , also known by its brand-name counterpart Vivitrol, is approved by the U.S. It comes as an oral tablet and intramuscular (IM) injection.

Communication 92

Communication Dosage FDA 92

STAT

JULY 6, 2023

Both are run by a husband-and-wife team that has received more than $17 million in NIH funding since 2003, according to the animal rights group. The company said it had started rolling submission of data for the shot with the FDA and is aiming to be the third vaccine maker to get an approval in the country after GSK and Pfizer.

Vaccines 67

Vaccines Pharmaceutical Companies Pharmaceutical Companies FDA 67

The Checkup by Singlecare

FEBRUARY 6, 2024

Food and Drug Administration (FDA). This drug stands out as one of the few non-stimulant options for the treatment of adults and children with attention-deficit hyperactivity disorder ( ADHD ) that are approved by the U.S.

Adverse Reactions 52

Adverse Reactions Mayo Clinic Labelling Compounding 52

ISPE

APRIL 13, 2023

1 More recently, regulators like the FDA have increasingly promoted the benefits of modeling (e.g., Topics in Chemical Engineering, 2003. Biopharma Adopts Mechanistic Modeling Mechanistic modeling has been widely used in the petrochemical industry for many decades, while biochemical producers have been slower to adopt. Melton, and E.

Compounding 98

Compounding FDA 98

pharmaphorum

OCTOBER 27, 2021

This year has been marked by one of the biggest developments in the search for new treatments for Alzheimer’s disease, after the US FDA approval of Biogen’s Aduhelm (aducanumab) in June. The monoclonal antibody was the first new drug to be approved for Alzheimer’s since 2003.

FDA 73

FDA Labelling 73

The Checkup by Singlecare

MARCH 21, 2024

A 2003 law prohibits government-sponsored plans like Medicare from covering weight loss medication. Consider a compounded version For drugs on the Food and Drug Administration (FDA) shortage list, compounding pharmacies can create and sell copies, often at lower prices than the brand-name versions.

Insurance 52

Insurance Insurance Coverage Mail-Order Pharmacies Dosage 52

pharmaphorum

MARCH 2, 2022

A recent publication showcased that the number of active clinical trials running that are researching various psychedelic therapies has increased rapidly from 2003 to 2021. With promising pre-clinical and clinical stage results, there are more and more therapeutic candidates being developed in this space.

Compounding 102

Compounding FDA 102

The Checkup by Singlecare

DECEMBER 27, 2023

Although a doctor may prescribe Fioricet when appropriate, it is not approved by the Food and Drug Administration (FDA) for treating migraine headaches. Still, clinical experience shows that it may be effective for mild or acute migraines. appeared first on The Checkup.

Mayo Clinic 52

Mayo Clinic Dosage FDA 52

STAT

JANUARY 5, 2024

Congress passed a law in 2003 to let wholesalers and pharmacists import Canadian drugs, but only if the FDA approved drug importation as safe, and until now the agency had refused to make that determination. The approval by the Food and Drug Administration is a breakthrough in a decades-long debate over whether to allow drug imports.

FDA 139

FDA 139

The Checkup by Singlecare

AUGUST 5, 2023

Cialis was initially approved in 2003 and has become a popular alternative to Viagra (sildenafil). Erectile Dysfunction Cialis is FDA-approved for ED and BPH. Benign Prostatic Hyperplasia Another FDA-approved use of Cialis is the treatment of BPH , which is characterized by an enlarged prostate.

Dosage 52

Dosage Insurance Mail-Order Pharmacies Insurance Coverage 52

The FDA Law Blog

JUNE 7, 2023

With the IRA Negotiation Program, Congress jettisoned the voluntary agreement approach in all but name.

Communication 45

Communication 45

Roots Analysis

JANUARY 3, 2024

However, Botulinum toxin was the real game-changer when it was approved for cosmetic use by the FDA in 2002. Afterwards, in 2003, the FDA approved Hyaluronic Acid Fillers (HA dermal fillers), bringing the much-anticipated innovation to all types of face and non-face augmentation products.

Hospitals 40

Hospitals Documentation FDA 40

The FDA Law Blog

OCTOBER 18, 2022

On October 17, 2022, FDA published the list of CDRH proposed guidances for FY 2023 (see here ). These are documents on the A-list, a list of prioritized documents that FDA intends to publish during FY2023. FDA published draft guidances for these topics in December 2021 ( here and here ).

Documentation 52

Documentation FDA Labelling 52

The Checkup by Singlecare

JANUARY 18, 2024

Food and Drug Administration (FDA) to treat congestive heart failure and hypertension. Key takeaways | Drug interactions | Food interactions | Other interactions | Avoiding interactions | When to see a doctor Carvedilol (Coreg) is a nonselective beta-adrenergic blocking agent ( beta blocker ) approved by the U.S.

Labelling 52

Labelling Hospitals FDA 52