European Pharmaceutical Review

JULY 17, 2023

billion for phased clinical trials of US Food and Drug Administration (FDA)-approved drugs between 2010-2019. million publications describing basic or applied research related to 386 of 387 drugs approved 2010-2019 with $8.1 This was ~10 percent of reported industry spending. billion (3.3

Documentation 98

Documentation FDA 98

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 105

STAT

JUNE 10, 2024

  In a paper published in JAMA Internal Medicine on Monday, researchers found that the percentage of women represented in high-risk medical device trials did not increase from 2010 to 2020. But stakeholders think agencies like the FDA could do more to incentivize the enrollment of women.

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FDA 138

pharmaphorum

JULY 7, 2021

The FDA indicated something was not well with Provention Bio’s filing for type 1 diabetes therapy teplizumab in April when it delayed its review. The data will be reviewed before a decision is made to submit it to the FDA to “support PK comparability or otherwise justify why PK comparability is not necessary.”

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FDA 98

pharmaphorum

APRIL 9, 2021

The FDA says it has uncovered “deficiencies” in the marketing application for Provention Bio’s much-anticipated drug teplizumab for the prevention of type 1 diabetes (T1D) that could delay its review. The study was a key element of the FDA filing, and the first ever evidence that a drug therapy could delay the onset of T1D.

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FDA Labelling 98

STAT

NOVEMBER 3, 2022

It was 2010. I was standing by the Long Island Sound in Sachem’s Head, Conn., in the shadow of an 11-foot-tall granite Stonehenge replica built by Jonathan Rothberg, a biotech entrepreneur, as he talked up his newest gadget, a tabletop DNA sequencer. Read the rest…

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FDA 131

The FDA Law Blog

SEPTEMBER 30, 2022

Valentine — On September 29, 2022, FDA approved Amylyx’s NDA for its drug, Relyvrio (sodium phenylbutyrate/taurursodiol), for treatment of patients with amyotrophic lateral sclerosis (ALS) (see FDA announcement here ). We would like to acknowledge FDA for its efforts on this devastating condition, ALS. By Frank J.

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FDA 98

STAT

JUNE 17, 2024

Perryman led the company from 2010 to 2019.  Under CEO Laura Perryman’s leadership, the company warped the design of their devices to earn more reimbursement money from insurers, resulting in unnecessary plastic parts that allowed doctors to claim around $18,000 more than they previously could. attorney Damian Williams.

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Insurance FDA 133

Pharmaceutical Commerce

JANUARY 25, 2024

Tesamorelin (Egrifta) was initially approved by the FDA in November 2010 for the treatment of lipodystrophy in patients also diagnosed with HIV.

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FDA 52

STAT

AUGUST 23, 2023

This FDA ruling will significantly expand access to high-quality contraception for folks across the country. When President Obama signed the ACA into law on March 23, 2010, reproductive health took a giant step forward with its commonsense yet revolutionary approach. However, true access will require affordability, too.

Insurance 97

Insurance FDA 97

The FDA Law Blog

AUGUST 12, 2024

As with other FDA-regulated products, such as human drugs and medical devices, the “regulatory review period” is composed of a “testing phase” and a “review phase.” FDA’s PTE regulations at 21 C.F.R. FDA guidance has been clear that that point for rolling submissions is when the last component has been submitted.

FDA 59

FDA 59

Pharmaceutical Technology

JUNE 12, 2023

In 2022, the FDA awarded VX-548 breakthrough therapy and fast-track designations for post-operative pain, and the drug is forecast to reach sales of $416m by 2029. Currently, Jazz Pharmaceuticals’s nabiximols is the only cannabinoid approved for pain, receiving approval in Israel, in August 2010.

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Immunization FDA 143

pharmaphorum

JULY 6, 2022

The FDA approves new cancer treatments in half the time of the EMA – but does faster mean better? A new cross-sectional study has found that the FDA green lit 95% of the 89 new oncology therapies approved between 2010 and 2019 before the EMA, with the Europeans trailing the Americans by a median of 241 days.

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FDA 98

IDStewardship

MARCH 12, 2023

BCPS, BCIDP Article Posted 12 March 2023 As a pharmacist serving as a preceptor to students and residents in the area of infectious diseases since 2010, I have always been on the hunt for good infectious diseases journal articles for my learners to read. Authored by: Timothy P. Gauthier, Pharm.D.,

Medication Guidelines 299

Medication Guidelines Documentation Labelling Hospitals 299

pharmaphorum

AUGUST 9, 2021

Sanofi has added another string to its Pompe disease therapy bow, after getting FDA approval for Nexviazyme, its latest therapy for the rare, inherited disorder. In 2010, Lumizyme’s label was expanded to the under-right group as well.

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FDA Labelling 98

The FDA Law Blog

FEBRUARY 26, 2024

Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

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FDA Dosage 59

STAT

AUGUST 8, 2023

White House budget experts are reviewing changes to the regulation of broadcast drug advertisements that the Food and Drug Administration proposed in 2010 , according to the Office of Management and Budget website. That proposal aimed to make commercials present drug risks in a manner that consumers notice and understand.

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FDA 98

pharmaphorum

MARCH 21, 2022

Shares in Provention Bio cratered last July when the FDA turned down its marketing application for type 1 diabetes therapy teplizumab. But armed with new data it has tried again, with the FDA due to make a decision on the new filing by 17 August.

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FDA 52

The FDA Law Blog

JULY 11, 2023

Koblitz — One of the most important questions FDA has to answer is whether a given product is appropriately characterized as a drug, biologic, device, food, cosmetic, or something entirely different. FDA further defined the term “protein” so that it includes any peptide product that has an amino acid sequence greater than 40 amino acids.

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FDA 95

pharmaphorum

NOVEMBER 18, 2022

At its second attempt, Provention Bio has secured FDA approval for teplizumab, as a treatment to delay late-stage type 1 diabetes (T1D) in at-risk individuals – becoming the first disease-modifying therapy for these patients. It is now in line for a $35 million equity investment by Sanofi following FDA approval.

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FDA Immunization 52

The Checkup by Singlecare

SEPTEMBER 25, 2023

RELATED: Ibuprofen savings | Acetaminophen savings Multiple studies, including a 2010 study focused on pain treatment after oral surgery, found the alternating ibuprofen and acetaminophen to be successful. Canadian Family Physician (2012) Maxigesic Rapid® tablets gain US FDA approval.

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Mayo Clinic Dosage Labelling FDA 111

The FDA Law Blog

NOVEMBER 1, 2023

Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Javitt & Michael D. Shumsky & Philip Won & Adrienne R. Gaulkin & Jeffrey N.

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FDA Hospitals Immunization 81

The FDA Law Blog

SEPTEMBER 11, 2023

Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents. Baumhardt, Senior Medical Device Regulation Expert & Adrienne R.

Documentation 64

Documentation FDA 64

Pharmaceutical Technology

JUNE 29, 2022

The US Food and Drug Administration (FDA) put a high-profile bluebird bio trial for sickle cell disease on partial clinical hold, and advisory panels deliberated over decisions involving gene therapies for amyotrophic lateral sclerosis (ALS), cerebral adrenoleukodystrophy (CALD), and beta-thalassemia.

Pharmaceutical Companies 98

Pharmaceutical Companies Pharmaceutical Companies FDA 98

pharmaphorum

APRIL 21, 2021

Shares in Hikma have rallied as it resumed the launch of its generic Advair Diskus in the US, after clearing up a final piece of bureaucracy with the FDA. The London-listed firm is one of several companies that had been trying to make generics of GlaxoSmithKline’s former respiratory diseases blockbuster for the US market.

Packaging 59

Packaging FDA 59

The Checkup by Singlecare

OCTOBER 20, 2023

A 2010 study found almost 50% of a group of 60 infertile males had an increase in sperm count after taking shilajit twice a day for 90 days. Supplements are not regulated by the Food and Drug Administration (FDA), so contamination is possible. Although promising, more research is needed to confirm if these benefits extend to humans.

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Immunization FDA 105

European Pharmaceutical Review

JULY 4, 2024

In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?

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FDA Documentation Pharmaceutical Companies Pharmaceutical Companies 103

Med Ed 101

MARCH 26, 2017

Since a significant number of media reports came out in 2010 due to information regarding the omeprazole and clopidogrel interaction, it has been hotly debated as to how to manage this drug interaction. The FDA also had a somewhat […].

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FDA 40

Druggist

MARCH 8, 2021

Although the mechanism underlying the wake-promoting action is fully understood, this effect is similar to other drugs , for example, amphetamines and methylphenidate , but with a distinct pharmacological profile (FDA, 2010). . FDA (2010). Joseph Kaleyias (2010). Modafinil alternatives: conclusion. eMC (2020).

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FDA Labelling 90

The FDA Law Blog

AUGUST 18, 2024

In 2012, the FDCA was modified to allow the submission of a De Novo request without the need for a prior 510(k), and set a target review time by FDA of 120 days. For example, FDA granted seven De Novos for COVID-19 related indications for use. It is important that FDA posts the decision summaries in a timely fashion.

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FDA Documentation Hospitals 69

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

The Checkup by Singlecare

MAY 1, 2025

Food and Drug Administration (FDA) in 2010. Since 2010, Victoza has had more FDA approvals, including one in 2019, where it was approved for pediatric patients with type 2 diabetes. He added, Then, in December 2024, Hikma Pharmaceuticals introduced a generic liraglutide product after receiving FDA approval.

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Dosage FDA Adverse Reactions Labelling 52

The FDA Law Blog

APRIL 17, 2024

Drug Take Back Days have made appearances each spring and autumn since 2010. Events over the years have led to the removal of more than 17.9 million pounds of unwanted medication across the country. Last October’s Drug Take Back Day removed 600,000 pounds (300 tons) of medication at almost 4,700 collection sites.

Controlled Substances 59

Controlled Substances 59

pharmaphorum

JANUARY 4, 2022

.” That will give Novartis additional time to build market share for Gilenya follow-up Mayzent (siponimod), a newer oral therapy for MS which was approved by the FDA in March 2019.

FDA 59

FDA 59

The Checkup by Singlecare

FEBRUARY 21, 2024

The Food and Drug Administration (FDA) does not offer any warning against using it to treat acid reflux during pregnancy. In a 2010 Danish study of data from 840,968 live births, babies exposed to PPIs during the first trimester of pregnancy had no increased prevalence of major birth defects compared to those who were not exposed.

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FDA 105

The Checkup by Singlecare

JUNE 24, 2024

Also known by the brand name Flexeril, this medication is FDA approved to treat muscle spasms associated with painful musculoskeletal conditions. Additionally, a 2010 study compared people who took ibuprofen alone, cyclobenzaprine alone, and both cyclobenzaprine and ibuprofen. Most of the time, it’s safe.

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FDA 105

The Checkup by Singlecare

APRIL 14, 2024

Gabapentin is a prescription medication that is FDA-approved to treat epilepsy and neuropathic pain caused by shingles. In a 2010 study , 18 people with primary insomnia received gabapentin treatment for 4 weeks. When taken for its FDA-approved indications, the usual dose of gabapentin varies.

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Dosage Labelling FDA 97