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1 Natural disasters have reached unprecedented levels in the past 5 years, with 2020, 2023, and 2024 being the most destructive and costly since before 1980. Taking precautions for storing medications and supplies is key to being prepared,” the FDA wrote. Innov Pharm. 2021;12(4):10.24926/iip.v12i4.4359. doi:10.24926/iip.v12i4.4359 5.
The package insert for sulopenem recommends taking it with food to maximize bioavailability. In case you are wondering, the FDA label does not list any hepatic dose adjustments. 2020 Jun;55(3):181-187. Orlynvah [package insert]. REFERENCES Al-Quteimat O, et al. Hosp Pharm. Dunne MW, et al. Clin Microbiol Infect.
Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.
Despite worried hand-wringing over a potential slowdown in FDA approvals under the new administration, the agency has been giving the go-ahead to drugs at a near record-setting clip. Meanwhile, the decision-making production has come during a major upheaval inside the FDA. Please let us know if you have feedback.
A new drug application for lorundrostat is expected to be filed with the FDA in 2025. doi:10.1016/20S0140-6736(22)02034-7 Aprocitentan (Tryvio) package insert. Widaplik (telmisartan, amlodipine, indapamide) package insert. Signal Transduction Targeted Therapy 2020; 5:101. mg/d, 1 mg/d, 2 mg/d, and placebo for 12 weeks.
FDA guidance documents illustrate labeling salt drugs and associated active moieties. The secondary label will specify the Drug ZA-ion amount per capsule and the equivalent Drug Z-salt amount consistent with FDA labeling guidance. Additional mole calculations are needed only for drug-name labeling per FDA guidance ( Figure 5b above).
What we've done is blend PillPack's innovative packaging with Amazon Pharmacy's user-friendly approach and affordability, so these patients can now get their medications in convenient, personalized packets and order everything online through our digital pharmacy.
Silver Spring, MD, USA - June 25, 2022: The FDA White Oak Campus, headquarters of the United States Food and Drug Administration, a federal agency of the Department of Health and Human Services (HHS). Highlights of five of the seven letters, the companies they were addressed to, and the significant red flags found by FDA are presented below.
Wegovy (semaglutide) is a prescription medication that’s approved by the Food and Drug Administration (FDA) to help with weight management in people ages 12 years and older with obesity and in adults who are overweight with at least one weight-related comorbid condition.
In a move towards transparency, the US Food and Drug Administration (FDA) has published more than 200 archived complete response letters (CRLs), which detail reasons for non-approval of drug applications submitted between 2020 and 2024. How will RFK Jr’s American dream for vaccines play out? Credit: Tada Images/Shutterstock.
The properties of thimerosal were documented to contribute to the safe use of multidose vials and packaging of vaccines, such as seasonal and pandemic influenza vaccines. 2 Currently, there are 3 FDA-approved seasonal influenza vaccines that contain a concentration of mercury, as evident from January 15, 2025, on the CDC website.
GSK’s plan to bring blood cancer drug Blenrep (belantamab mafodotin) back to markets has hit a stumbling block, after the US Food and Drug Administration (FDA) identified eye safety concerns ahead of a meeting to discuss the therapy’s benefit-risk ratio. How will RFK Jr’s American dream for vaccines play out? 1take1shot via Shutterstock.
Since 2008, the Association of Chemistry and Pharmacy of Uruguay has played an active role in promoting a National Health Surveillance Agency, and in 2020 the government attempted to launch a similar agency but it ultimately failed. How will RFK Jr’s American dream for vaccines play out?
Founded in 2020, Scorpion raised $420m in the next five years while partnering with several pharmaceutical firms and producing six development candidates, three of which are now undergoing clinical trials. Give your business an edge with our leading industry insights.
Licensing deals between US and Chinese biopharma companies hit record highs last year, a 280% increase from 2020, according to analysis by GlobalData. How will RFK Jr’s American dream for vaccines play out? Give your business an edge with our leading industry insights.
Unprecedented Move Previously, the FDA had not routinely shared CRLs publicly. A 2015 cross-sectional study published in BMJ found that drug developers omitted around 85% of safety and efficacy concerns noted by the FDA in their public statements (2). References FDA. regulatory transparency standards. Press Release.
By GlobalData Learn more about Strategic Intelligence Zurzuvae, whose ownership rights will now transfer to Supernus, is the only US Food and Drug Administration (FDA)-approved pill to treat postpartum depression. The acquisition affords Supernus a dominant position in the market. Co-developed with Biogen, Zurzuvae earned Sage $36.1m
Abigail Beaney July 18, 2025 Share Copy Link Share on X Share on Linkedin Share on Facebook The FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the benefit/risk profile of GSK’s Blenrep. The FDA will consider the recommendation of the committee as it finalises its review on Blenrep in advance of the 23 July PDUFA date.
Given that multiple work packages may often start or end together, or else take longer than others ( Figure 1 ), the introduction of new PAT requires assessment and planning by multiple departments. Figure 1 : Process analytical technology implementation in (bio)pharmaceutical GMP manufacturing. References 1. Bliesner DM.
11-13 Recent reports from US Food and Drug Administration (FDA) authors concluded that AI can usefully be applied to some aspects of ICSR (individual Case Safety Reports) processing and evaluation, but the performance of current AI algorithms requires a human-in-the-loop to ensure good quality. FDA Discussion Paper And Request For Feedback.
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.
The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. This draft guidance builds on recommendations published by the agency in 2020.
On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. This continuously growing pipeline of pharmaceutical drug products has inadvertently led to an increase in the demand for their associated primary packaging and Secondary Packaging solutions. . trillion in 2023.
The NDA for Abicipar pegol, which utilizes DARPin technology was rejected by the FDA secondary to concerns of inflammation with the 2 mg dose”. What current topic will you be addressing in your presentation, and what would you say makes it relevant to 2020? “We 23 rd -24 th November 2020. Ophthalmic Drugs Conference.
After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
billion since 2020. It will boost the site’s its capacity for parenteral filling, device assembly and packaging even further. The plant in Research Triangle Park has already received hefty investment from Lilly, and the new tranche will take the tally to $1.7
Already scrambling to refile its obeticholic acid (OCA) drug for non-alcoholic steatohepatitis (NASH) after the FDA rejected it last year, Intercept Pharma was hoping for more luck in Europe, but has now withdrawn its EU marketing application. Shares in Intercept slipped around 15% after it announced the news.
2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). FDA is authorized to charge an annual facility fee for OTC monograph drug facilities. FDA will not refund any fees that have been incurred already). By Riëtte van Laack & Deborah L.
By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.
It can also treat parasitic infections, like giardia, and is frequently used off-label (for a non-FDA-approved use) to help treat Crohn’s disease, bite wounds, and oral infections. Additionally, i n the case of bacterial vaginosis, this may improve your outcome, per a 2020 study.
Check the drug’s packaging and label carefully before giving it to your pet. The FDA says Zyrtec’s effects typically last around 24 hours for humans, and studies show that its elimination half-life is around 8.3 Important Note: While standard Zyrtec is safe for dogs , never give a dog Zyrtec-D. How quickly does Zyrtec work in dogs?
Always follow the directions on the packaging or consult a healthcare professional if you have concerns about the appropriate dosage. In addition, the FDA label for the nighttime forms of Mucinex containing acetaminophen recommends avoiding three or more drinks per day.
As does the US Food and Drug Administration (FDA): REMS Assessment: Planning and Reporting Guidance for Industry Draft Guidance. Patient-Focused Drug Development: Collecting Comprehensive and Representative Input Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders; June 2020. Available from: [link].
For people with Type 2 diabetes, Ozempic is a game-changer: This FDA-approved drug not only lowers blood sugar but can also help people lose weight. American Diabetes Association (undated) Achieving Type 2 diabetes remission through weight loss , National Institute of Diabetes and Digestive and Kidney Diseases (2020) Carbohydrates.
If a patient wants to report an adverse reaction to the FDA, they need to fill out Form 3500B. On the other hand, if medication is dispensed in the drug company’s original packaging, the law requires an expiration date along with lot number and NDC number ( StatPearls , May 1, 2023 ). The FDA does virtually no testing.
There’s currently no generic alternative for Stelara, but in 2023, the Food and Drug Administration (FDA) approved a biosimilar substitute called Wezlana. Getting a drug approved by the FDA is a very expensive process,” says rheumatologist Stella Bard, MD. In October 2023, the FDA approved Wezlana, a biosimilar for Stelara.
Zyrtec was approved by the United States Food and Drug Administration (FDA) in 1995. The first generic of prescription Zyrtec, cetirizine, was approved by the FDA in 2008, around the time the medication became available over the counter. For example, one 2020 study from Taiwan compared brand-name and generic antidepressants.
Of the 175 new drugs approved by the US Food and Drug Administration (FDA) between 2016 and 2019, most were biologics. The payload is packaged inside a dissolvable needle, loaded within a microsyringe that is attached to a folded, self-inflating balloon. Biologics represent an increasingly large part of the pharmaceutical industry.
new combined oral contraceptive was approved by the FDA (Nextstellis®) in April 2021. In conclusion, Nextstellis is a recent FDA-approved oral contraceptive that offers patients another alternative for birth control. Nextstellis (Drospirenone and Estetrol) [package insert]. Published April 7, 2020. 2020, [link].
Four factor prothrombin complex concentrate (4F-PCC) is FDA approved to reverse vitamin K antagonists (VKAs) such as warfarin in adult patients with acute major bleeding or a need for an urgent surgery/invasive procedure. Dosing According to Package Insert. Kcentra (prothrombin complex concentrate [Human]) [package insert].
The FDA, PIC/S, and WHO have all emphasized the importance and benefits of data flows in their guidance on data integrity. The goal is to break down complex processes into easy-to-grasp packages, including data privacy and information technology (IT) security. In the fourth and last step, the defined work packages are executed.
It’s now globally accessible due to Gilead’s work with a network of generic manufacturers and their ability to sign licensing agreements just days after the US FDA registered its authorisation. If you get past the regulatory hurdles, then you have to look at labelling requirements, packaging requirements, and quality assurance requirements.”.
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