FDA Law Blog

APRIL 2, 2024

Perhaps unsurprisingly given the extraordinary focus on drug pricing in the last decade, generic competition—FDA’s only real way to have an effect on drug pricing—tops this year’s list. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

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STAT News

MARCH 16, 2023

regulators approved dozens of inhalers to treat asthma and chronic obstructive pulmonary disease over a recent 15-year period, but a new study found that generic companies have only twice successfully pursued an established pathway to create lower-cost, rival products. Continue to STAT+ to read the full story…

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Pharmaceutical Technology

FEBRUARY 24, 2023

She also cautioned against believing that all of the problems with Europe’s medicines can be solved with regulation. If you measure everything on faster, I’m not sure Europe will always come out ahead.” Outdated law Whatever the outcome, everyone involved agrees that the legislation needs a makeover. “We

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Pharma in Brief

NOVEMBER 5, 2023

201/96 under the Ontario Drug Benefit Act ( ODBA Regulations ). 935 under the Drug Interchangeability and Dispensing Fee Act ( DIDFA Regulations ). In both Regulations, the new exception would apply where the drug product is “not a new drug as defined in the Food and Drug Regulations ”.

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Pharmaceutical Technology

JUNE 5, 2023

Earlier this year, Sun Pharmaceutical Industries , one of India’s largest generic drug producers, reported a major cybersecurity breach , impacting its business operations. Regulators need to work together with industry to certify hot patches to quickly fix vulnerabilities while maintaining pharmaceutical quality,” adds Fracchia.

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Outsourcing Pharma

OCTOBER 12, 2020

Technology impacting generic drugs include artificial intelligence, telemedicine, fraud-preventing digital solutions and more, according to a report.

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World of DTC Marketing

JUNE 22, 2022

The company has hired former senior health regulators to help it navigate America’s healthcare bureaucracy. . Then there is the cost of generic drugs. bil­lion in 2020 if it had pur­chased 77 of 89 drugs from Cuban’s firm. Generic drugs versus branded is also a considerable expense.

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The Pharma Data

MARCH 15, 2022

Agency Supports Development of Complex Generic Drug-Device Combination Product to Improve Competition and Access to More Affordable Medicines. This complex generic drug-device combination product, which is a metered-dose inhaler, should not be used to treat acute asthma attacks. Today, the U.S.

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BioPharma Reporter

DECEMBER 22, 2022

Expanding generic drug competition and a decline in the demand for COVID-19 vaccines and therapies have brought down the aggregate market capitalization of the global top 20 biopharmaceutical companies by 9.1%.

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Camargo

SEPTEMBER 8, 2021

devices must be regulated as devices, and drugs—if they do not also satisfy the device definition—must be regulated as drugs.”. The drugs approved via PANDAs are often used as the reference listed drug (RLD) for ANDAs under 505(j), and they can also be used as the listed drug for 505(b)(2) applications.

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FDA Law Blog

JANUARY 22, 2024

Led by former federal prosecutor Jill Furman, OC is charged with shielding consumers “from poor quality, unsafe, and ineffective drugs through compliance strategies and risk-based enforcement actions.” This is another area in which FDA works with industry to try to ensure voluntary compliance from regulated entities. Clinical Trials.

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FDA Law Blog

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. His presentation will focus on “MoCRA is Here – Now What? We can offer our readers a special discount for the event.

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Outsourcing Pharma

OCTOBER 5, 2021

The US Department of Justice reports three generic drug manufacturers have been socked with the hefty fine to resolve alleged False Claims Act violations.

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Camargo

NOVEMBER 11, 2020

Presumably, Antares’ long-established 90-person urology sales force can achieve pull-thru of this drug product. Labeling regulations prohibit reminder ads for products with boxed warnings, which the FDA requires when a drug product has very serious risks.

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Pharma in Brief

APRIL 29, 2021

Therefore, the new prohibition provided a “humanitarian exception” which allowed financial support to continue in cases to be determined by regulation. Notably, the coming into force of the prohibition was suspended pending the adoption of such regulation. 2] Both the prohibition and the regulation came into force on April 15, 2021.

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FDA Law Blog

JUNE 28, 2023

1844 – Animal Drug and Animal Generic Drug User Fee Amendments of 2023. The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food.

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FDA Law Blog

AUGUST 17, 2023

Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. § FDA regulations, at 21 C.F.R. 355(j)(2)(A)(v). patients in harm’s way.”

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FDA Law Blog

FEBRUARY 26, 2024

Even more definitively, FDA wrote: Thus, when the BPCI Act was passed by Congress in 2009 and signed into law on March 23, 2010, the statutory term “strength” in section 505(j)(2)(A)(iii) of the FD&C Act had an existing, well-established administrative meaning that reflected both the total drug content (e.g.,

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FDA Law Blog

AUGUST 4, 2022

Join members of the Judiciary and leading pharmaceutical patent litigators from brand name and generic drug companies at the American Conference Institute’s 8th Annual Paragraph IV Disputes Master Symposium taking place September 21-22, 2022, in Chicago!

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.

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pharmaphorum

JULY 28, 2022

Logistical challenges of getting the right materials in the right place remain two years after the pandemic began, causing significant drug shortages to end-users. Many of the medicines most badly affected by these shortages are generic drugs to treat common conditions such as diabetes and heart disease.

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Pharmaceutical Technology

NOVEMBER 21, 2022

Japan’s Ministry of Health, Labour and Welfare (MHLW) has introduced a series of pricing regulations to reduce the national health insurance (NHI)-listed drug prices, including the implementation of annual off-year price revisions.

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Pharma in Brief

JANUARY 9, 2022

These policy initiatives included reforms to the Patented Medicine Prices Review Board ( PMPRB ), the Patented Medicines (Notice of Compliance Regulations) ( PM(NOC) Regulations ), the Patent Rules , and other regulatory matters at Health Canada. Proposed amendments to the PM(NOC) Regulations were also introduced in 2021.

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Pharmaceutical Technology

OCTOBER 28, 2022

To demonstrate bioequivalence for a generic small molecule drug, a company must carry out a Phase I clinical trial in healthy individuals to ensure that the area under the curve and maximum plasma concentration for their drug is equivalent to that of the brand name drug.

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pharmaphorum

JULY 29, 2021

The drugmaker specialises in selling generic drugs that are hard to manufacture, which places a barrier to widespread generic competition. The regulator said that in addition to the fines, the NHS may choose to pursue the companies for damages in the courts. ” Advanz itself was directly fined £40.9 million and £51.9

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Pharmacy Checkers

SEPTEMBER 10, 2020

Food and Drug Administration to make sure those drugs will work as directed by their prescribers. While the FDA is known as a top drug regulator, for all intents and purposes, Valisure is saying that you can’t fully trust them. Because they don’t do adequate testing to prove safety and effectiveness of drugs.

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FDA Law Blog

MARCH 26, 2024

Though Teva listed the asserted patents as “drug product” patents, FTC explains that “none of the [patents in suit] mention any drug in their claims, much less the active ingredient in ProAir HFA, albuterol sulfate.” (FTC also notes that the last expiring patents covering albuterol sulfate expired in 1989.)

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FDA Law Blog

JUNE 2, 2022

Since 1984, generic drugs have been approved under ANDAs pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA); before 1984, no formal mechanism for an ANDA existed so FDA used sections 505(b) and 505(c) to approve follow-on drugs based on the Agency’s previous findings of safety and efficacy.

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The Pharma Data

MAY 7, 2021

International regulators and WHO call for wider public access to clinical data ( EMA ). EU regulator begins real-time review of GSK-Vir COVID-19 antibody drug ( Reuters ) ( Press ). Two drug makers, two commercial launches — with divergent results ( STAT ). Generic Drug Cos. .

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FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers.

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Pharmaceutical Technology

NOVEMBER 29, 2022

The drug is also known for its illegal recreational use. In March 2019, the American regulator approved esketamine , an enantiomer of ketamine, for use in treatment-resistant depression as a nasal spray. Since ketamine is a generic drug, it is not lucrative to study for pharmaceutical companies, he adds.

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The Pharma Data

JULY 29, 2021

The substitution may occur at the pharmacy, a practice commonly called “pharmacy-level substitution” – much like how generic drugs are substituted for brand name drugs, subject to state pharmacy laws, which vary by state. Biosimilars marketed in the U.S.

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Pharma in Brief

JUNE 21, 2020

On June 19, 2020, the Patented Medicine Prices Review Board ( PMPRB ) launched its consultation on revised Draft Guidelines to implement the amended Patented Medicines Regulations. Amendments to the Patented Medicines Regulations are scheduled to come into force on January 1, 2021. Background. New patented medicines.

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FDA Law Blog

AUGUST 21, 2023

Brand drugs, generic drugs, and medical devices alike have all been the target of state failure-to-warn litigation; in a recent case, OTC acetaminophen is the target. The GAO Report further explained that the agency did not have the resources to regulate the estimated 100,000 OTC drugs marketed through the monograph process.

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pharmaphorum

AUGUST 28, 2020

An androgen receptor inhibitor, Winlevi (clascoterone) has been cleared by the US regulator for the treatment of acne in patients 12 years and older and is due to be launched early next year, according to the company.

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pharmaphorum

JUNE 3, 2021

The FDA approval of Alkermes’ new antipsychotic drug Lybalvi couldn’t have gone any better for the company, but it could still face a big challenge positioning the new drug in the highly genericised market.

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FDA Law Blog

MARCH 13, 2024

156 for certain FDA-regulated products, we know what you were thinking. 156(d) (and the PTO’s PTE regulations at 21 C.F.R. That regulation is pretty clear. Take, for example, a recent instance this blogger faced when submitting generic drug Controlled Correspondence to FDA on behalf of a prospective generic drug applicant.

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