FDA revises biosimilar guidelines for clearer drug labelling
Pharmaceutical Technology
SEPTEMBER 18, 2023
The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.
This site uses cookies to improve your experience. By viewing our content, you are accepting the use of cookies. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country we will assume you are from the United States. View our privacy policy and terms of use.
Pharmaceutical Technology
SEPTEMBER 18, 2023
The FDA released a draft guidance giving advice on the correct labelling of biosimilar and interchangeable biosimilar products.
Drug Topics
FEBRUARY 9, 2023
Researchers evaluated how changes in USP labeling standards have affected adherence across multiple classes of drugs.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Fierce Pharma
SEPTEMBER 15, 2023
With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from the Inflation Reduction Act and a trio of | With the potential for more than two dozen label expansions on the horizon, Bristol Myers Squibb bets its pipeline can help it withstand the pressure from (..)
Pharmaceutical Commerce
SEPTEMBER 19, 2023
The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
BioPharm
SEPTEMBER 18, 2023
The draft guidance document discusses the development of labeling for proposed biosimilars and interchangeable biosimilars for submission under section 351(k) of the Public Health Service Act.
Fierce Pharma
JUNE 16, 2023
Merck’s cancer star Keytruda could be on its way to an updated label in HER2-positive stomach cancer after showing it can stave off tumor progression in a combination study.
pharmaphorum
AUGUST 25, 2023
CVS Health launches private label biosimilars unit Phil.Taylor Fri, 25/08/2023 - 08:07 Bookmark this
pharmaphorum
AUGUST 2, 2023
Samsung seeks 'interchangeable' label for Humira biosimilar Phil.Taylor Wed, 02/08/2023 - 10:37 Bookmark this
Drug Store News
JULY 6, 2023
Know & Love will offer a wide range of affordable and clean-label products, including food, beverage and household items.
Fierce Pharma
SEPTEMBER 1, 2023
When it comes to heart failure medication, a labeling mix-up can have dire consequences. Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg mg dose, and vice versa.
Drug Store News
JULY 26, 2023
Dollar General is debuting more than 100 new items in its Clover Valley private label line in 2023.
pharmaphorum
JUNE 28, 2023
AbbVie, Genmab eye label expansion for Epkinly Phil.Taylor Wed, 28/06/2023 - 13:04 Bookmark this
STAT
AUGUST 21, 2023
A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán.
The FDA Law Blog
MAY 11, 2023
GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”
Drug Topics
JULY 12, 2023
Recent safety data also allowed four adverse events to be removed from the label.
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. A recent state law failure-to-warn case in the SDNY makes that very point.
STAT
JUNE 20, 2023
Much of the Americas already has so-called front of package labels — small symbols printed on packaged foods that alert consumers when a food is high in certain unhealthy nutrients like sodium or saturated fat. Now, the Food and Drug Administration is embarking on a major study to test front of package labels here in the U.S.,
Pharmaceutical Technology
MARCH 22, 2023
What lies ahead for RFID and smart labelling Volpe says “the future is bright” for smart technologies that identify, monitor, and track medications through the supply chain. RFID is an important facet of smart labelling and its evolution, but not the only one.
Roots Analysis
SEPTEMBER 13, 2023
The conjugation of biomolecules is also referred to as biomolecule labeling when the modification with conjugates lead to detection ( direct / indirect ) for bioimaging and immunoassays. The below figure highlights the different types of molecular conjugates and labels that can be conjugated with various molecules.
Pharmaceutical Technology
APRIL 11, 2023
This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.
Drug Store News
JULY 6, 2023
Several beauty trends will be revealed at PLMA’s 2023 annual Private Label Trade Show, Nov. 12-14 in Chicago.
Pharmaceutical Technology
MAY 16, 2023
The US Food and Drug Administration (FDA) has approved expanded labelling for Cumberland Pharmaceuticals’ Caldolor therapy to include use in infants. Caldolar is an intravenously provided formulation of ibuprofen which may now be administered to treat pain and fever in patients from three months to six months of age.
Pharmaceutical Commerce
JULY 10, 2023
Platform is expected to streamline the label management process.
Fierce Pharma
MAY 15, 2023
UPDATED: After Supreme Court rejection, Teva mulls options in GSK 'skinny label' feud fkansteiner Mon, 05/15/2023 - 10:59
PharmExec
JULY 31, 2023
Insights into current practice of global pharma labeling, including shortcomings and potential improvements.
BuzzRx
JANUARY 27, 2023
The term “on-label use” of a drug may seem unfamiliar to most people. In short, this practice is referred to as “off-label” drug use. Surveys have shown that approximately 1 in 5 prescriptions in the US are for off-label use. In certain populations of patients, off-label drug use is even higher.
pharmaphorum
JUNE 6, 2023
ASCO: Enhertu data sets up tumour-agnostic label bid Phil.Taylor Tue, 06/06/2023 - 08:26 Bookmark this
Pharmaceutical Technology
MARCH 16, 2023
Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz.
Drug Store News
OCTOBER 19, 2022
Lannett's deal call for another pharmaceutical company to purchase and distribute under a private label a limited number of certain other Lannett owned generic drug products.
STAT
MARCH 30, 2023
Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. solicitor general urged the U.S.
Drug Store News
DECEMBER 7, 2022
L’Oréal’s Product Impact Labeling gives items a ranking on a scale from A to E by considering 14 planetary impact factors.
Roots Analysis
MARCH 8, 2023
In recent years, the use of smart labels allows the developer to convey a greater amount of information about the product to the consumers, without the need for additional packaging space. Further, smart labels play a critical role in the manufacturing of pharmaceuticals.
PharmExec
AUGUST 23, 2023
Five industry experts discuss labeling challenges and trends in modernization.
Pharmacy Times
JANUARY 16, 2023
Label update removes a previous limitation that stated the medication should not be used as initial therapy for treating patients with type 2 diabetes.
The Checkup by Singlecare
JANUARY 26, 2023
If you’ve worked in a community pharmacy, you’ve likely had the same frustrating conversations about prescription labels over and over. Due to variability in health literacy, studies show that Americans’ level of understanding of prescription label instructions ranges from 53% to 89%.
Pharmaceutical Technology
JUNE 19, 2023
Issues with regulatory requirements and documentation can also cause significant delays, while any inaccuracies in translations on labelling can mean that dosage and storage information is not correctly understood or followed. And accurate labelling and translation are critical for this sector.
Pharmaceutical Commerce
JULY 27, 2023
Purchase helps expands business’ label and packing services.
Fierce Pharma
JANUARY 4, 2023
Particulates, label issues prompt separate recalls for Pfizer's Hospira and Accord. Wed, 01/04/2023 - 11:35.
Pharmaceutical Technology
AUGUST 18, 2023
As restrictions on abortion drug mifepristone loom, doctors and patients are looking to off-label misoprostol as an alternative.
The FDA Law Blog
DECEMBER 12, 2022
Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.
Fierce Pharma
DECEMBER 19, 2022
AbbVie's Vraylar, carrying $4B sales target, wins FDA label expansion in depression. Mon, 12/19/2022 - 11:13.
Pharmaceutical Technology
APRIL 17, 2023
The US Food and Drug Administration (FDA) has approved an update to the indications and usage section of Horizon Therapeutics ’ Tepezza (teprotumumab-trbw) label to specify its use to treat thyroid eye disease (TED) patients regardless of disease activity or duration. The FDA’s approval was granted in January 2020.
STAT
MARCH 14, 2023
Saying genetics researchers inconsistently and inappropriately use racial and ethnic labels that fail to capture the complex patterns of human genetic variation, the National Academies of Sciences, Engineering, and Medicine issued a report Tuesday calling for a transformation in how such descriptors are used.
Fierce Pharma
MARCH 20, 2023
Novo Nordisk, Eli Lilly replenish Type 2 diabetes stars Ozempic, Mounjaro after off-label weight-loss boom fkansteiner Mon, 03/20/2023 - 10:09
Expert insights. Personalized for you.
We have resent the email to
Are you sure you want to cancel your subscriptions?
Let's personalize your content