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【EXPERT Q&A】What are the major steps in an FDA application?

Drugdu.com expert’s response: The steps for FDA application can be summarized into the following core stages, taking into account the commonalities and differences among product types (food, drugs, medical devices, etc.). The specific process is as follows: I. Preliminary Preparation: Clarify Product Classification and Regulatory Requirements 1. Determine Product Classification Food: Classified into general food, special food (e.g., infant food), dietary supplements, etc. Some require FCE/SID registration (e.g., low-acid canned food). Drugs: Classified into new drugs (NDA), generic drugs (ANDA), biological products (BLA), etc., with different application paths for each category. Medical Devices: Classified into Class I (low risk), Class II (medium risk), and Class III (high risk) based on risk level, determining the application type (e.g., 510(k), PMA). 2. Confirm Regulatory and Standard Requirements Comply with regulations such as the Federal Food, Drug, and Cosmetic Act (FDCA) and the Medical Device Amendments. Reference international standards (e.g., ISO 13485, IEC ...
- Source: drugdu
- 148
- March 18, 2026
Kanghua Bio’s ACYW135 group meningococcal conjugate vaccine has been approved for clinical trials, marking another key breakthrough in its R&D pipeline.

On March 16, 2026, Chengdu Kanghua Biological Products Co., Ltd. (stock code: 300841, stock abbreviation: Kanghua Bio) issued an announcement stating that its ACYW135 group meningococcal conjugate vaccine has officially obtained the “Drug Clinical Trial Approval Notice” issued by the National Medical Products Administration, and is authorized to conduct clinical trials against epidemic cerebrospinal meningitis (hereinafter referred to as “meningococcal”) caused by meningococcal groups A, C, Y and W135. This marks a core step forward for this domestic vaccine company in the technological upgrading and pipeline improvement of the meningococcal vaccine field. According to the announcement, the ACYW135 group meningococcal conjugate vaccine, which has been approved for clinical trials, has the application number CXSL2501077, is classified as a Class 3.3 drug, and has the clinical trial approval notice number 2026LP00672. The National Medical Products Administration’s approval conclusion indicates that the vaccine meets the relevant requirements for drug registration and approves ...
- Source: drugdu
- 169
- March 17, 2026
Humanwell Healthcare Group has released another blockbuster product! Its marketing application for acetaminophen/oxycodone extended-release tablets has been accepted.

Today (March 12, 2026), according to the latest announcement on the CDE website, Yichang Renfu Pharmaceutical’s application for marketing authorization of acetaminophen-oxycodone extended-release tablets , a Class 2.2 improved new drug , has been accepted. As a leading company in the domestic anesthesia and analgesia field, Renfu Pharmaceutical’s move not only enriches its analgesic product pipeline but also targets unmet clinical needs in the treatment of moderate to severe pain. Image source: CDE official website Acetaminophen/oxycodone extended-release tablets are a potent centrally acting analgesic , composed of the opioid analgesic oxycodone and the nonsteroidal anti-inflammatory drug acetaminophen. The two work synergistically to ensure analgesic efficacy while optimizing medication safety. Its core competitive advantage lies in its extended-release formulation design—compared to existing immediate-release formulations, this extended-release tablet allows for prolonged administration, reducing the frequency of dosing and significantly improving patient adherence. With its advantages of ” potent analgesia + optimized safety ...
- Source: drugdu
- 125
- March 17, 2026
Eli Lilly invests $3 billion in China

Recently, Eli Lilly announced plans to invest a total of $ 3 billion over the next ten years to fully expand its supply chain capacity in China . According to the plan, the $3 billion investment will adopt a dual-track model of ” internal expansion + external cooperation “: on the one hand, it will leverage the technological and talent advantages of the Suzhou factory to strengthen the synergistic production capacity of incretin injection; on the other hand, it will add oral solid dosage form production capacity in Beijing and cooperate with multiple local production partners to release incremental production capacity. As a key move in this round of investment, Eli Lilly also announced a strategic partnership with Kanglong Chemical , a leading domestic CDMO company , on the same day. The initial investment of $200 million will support Kanglong’s technological capabilities, with plans to gradually expand the scale as ...
- Source: drugdu
- 168
- March 17, 2026
Medtronic invests $550 million in neurointerventional surgery.

According to recent foreign media reports, global medical device giant Medtronic announced that it will acquire Scientia Vascular for $550 million to strengthen its stroke treatment portfolio. Image source: Fierce Biotech Scientia Vascular is a company specializing in the manufacture of specialized guidewires, microcatheters, and access products for reaching complex blood clots deep in the brain. According to data from PharmNet Medical Devices, the company has already launched 16 products in the United States. In 2021, Scientia completed a $50 million funding round, which the company reportedly used to accelerate sales, marketing, and new product development in its core neurovascular stroke market, as well as peripheral vascular and interventional oncology-related markets. Scientia’s process involves etching slots into a solid nickel-titanium alloy tube to form a closed loop and interconnected beams—allowing the guidewire to effectively transmit torque while meandering through the brain’s small, winding blood vessels. The company states that this ...
- Source: drugdu
- 142
- March 17, 2026
Roche’s blockbuster new drug receives approval for a new indication, becoming the world’s first to do so.

Diffuse large B-cell lymphoma ( DLBCL) is the most common type of non-Hodgkin lymphoma (NHL), accounting for 31%–34% of NHL cases globally and 45.8% in China. The incidence rate increases with age. Even after first-line treatment, 30%–40% of DLBCL patients face relapse or refractory outcomes, resulting in a poor prognosis and challenging survival.On March 13, 2026, according to the latest announcement on the official website of the National Medical Products Administration (NMPA) of China , Roche (China) Investment Co., Ltd. ‘s application for a new indication for injectable veportuzumab has been approved for marketing in China . According to Roche’s press release, the indication is: this product in combination with rituximab , gemcitabine, and oxaliplatin (Pola-R-GemOx) for adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not suitable for hematopoietic stem cell transplantation. Public information shows that vedotin (Urithema®, Polivy®) is an antibody-drug conjugate (ADC) targeting ...
- Source: drugdu
- 152
- March 17, 2026
Lunan Pharmaceutical’s carfilzomib API receives dual approval from China and the US for market launch.

Recently, Shandong New Era Pharmaceutical Co., Ltd., a subsidiary of Lunan Pharmaceutical Group, received a marketing authorization notice for carfilzomib issued by the National Medical Products Administration . This approval further enriches the company’s anti-tumor active pharmaceutical ingredient (API) product line. The product, manufactured using the same production line and process, has also been submitted for US approval, providing a better option for domestic and international pharmaceutical formulation customers. Carfilzomib, as a second-generation proteasome inhibitor, exerts significant anti-proliferative and pro-apoptotic effects on tumor cells by irreversibly binding to the 20S proteasome active site. Its high selectivity results in a lower risk of neurotoxicity, and it is well tolerated by patients. Clinical data confirm that it has a reliable safety advantage in the treatment of multiple myeloma and is the preferred clinical option. Established in 2017, the International Drug R&D Center adheres to an international strategy of “based in China, radiating ...
- Source: drugdu
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- March 17, 2026
Dentima Krasnodar

Organiser：ITE Group, UK Time：May 27 – May 29, 2026 Address：Zipovskaya str., 5 350010, Krasnodar, Russia Exhibition hall：Krasnodar Expo Center Product range: Medical: Medical supplies, medical products, medical consumables, medical equipment Rehabilitation: Elderly rehabilitation, rehabilitation equipment and materials, rehabilitation medicine, rehabilitation training, rehabilitation devices, assistive devices and equipment for the disabled Healthcare: Health products, healthcare appliances, health food, healthcare equipment and related items About Dentima Krasnodar： The Russian Medical Exhibition (Dentima Krasnodar) is one of the leading medical exhibitions in southern Russia. Each year, it brings together doctors, manufacturers, and suppliers of medical equipment and materials from many regions of Russia and foreign countries. It serves as a platform for professional exchange and sharing of experiences, showcasing the latest equipment and technologies. The exhibition will attract an increasing number of exhibitors and visitors to participate, enabling them to connect and interact regarding the latest market innovations and profitable business ...
- Source: drugdu
- 118
- March 17, 2026
Unknown Risks Associated with Tirzepatide + Vitamin B12

On March 12, 2026, Eli Lilly and Company issued an open letter to the public, warning of potential safety risks associated with compounded medications that mix tirzepatide with vitamin B12. Lilly stated that its testing revealed a chemical reaction between tirzepatide and B12 in compounded formulations, producing significant levels of unknown impurities. The short term and long term effects of these impurities on the human body remain completely unknown. This warning has once again drawn public attention to the gray area of compounded drug formulations. Unknown Impurities Detected Safety Profile Completely Unknown In its open letter, Eli Lilly disclosed that it had tested commercially available compounded products combining tirzepatide with B12 (including methylcobalamin, hydroxocobalamin, or cyanocobalamin) and found them to contain substantial levels of unknown impurities. These impurities are products of a chemical reaction between tirzepatide and B12. Lilly emphasized that no research data exist regarding the pharmacological properties ...
- Source: drugdu
- 145
- March 16, 2026
A New Generation of 10-Billion-Level Anticoagulant Drug Is Coming

Anticoagulants occupy a unique niche on the global bestselling drugs ranking. Unaffected by sudden pandemics or short-lived market trends, they have long secured a core position in the global pharmaceutical market driven by rigid clinical demand. In 2025, apixaban ranked sixth globally with $14.4 billion in worldwide sales, earning its title as the undisputed “King of Anticoagulants”. This sales figure not only surpassed blockbuster oncology drugs such as Opdivo and daratumumab, but also exceeded popular chronic disease medications like dapagliflozin. Beneath this prosperity, however, patents are expiring, and the billion-dollar era of the “xaban” class is drawing to a close. Yet the anticoagulant sector will not halt its progress: a new generation of blockbuster drugs is on the horizon. / 01 / An Unmatched Commercial Logic The enormous size of the anticoagulant market is hardly surprising. As the name suggests, antithrombotic drugs inhibit thrombus formation, promote thrombolysis, or prevent ...
- Source: drugdu
- 162
- March 16, 2026

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