The FDA’s Drug Review Process: Ensuring Drugs Are Safe and Effective

New Drug Approvals

How Drugs are Developed and Approved

The mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in this country are safe and effective. CDER does not test drugs, although the Center’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety, and effectiveness.

CDER is the largest of FDA’s five centers.   It has responsibility for both prescription and nonprescription or over-the-counter (OTC) drugs. For more information on CDER activities, including performance of drug reviews,  post-marketing risk assessment, and other highlights, please see the CDER Update: Improving Public Health Through Human Drugs The other four FDA centers have responsibility for medical and radiological devices, food, and cosmetics, biologics, and veterinary drugs.

Some companies submit a new drug application (NDA) to introduce a new drug product into the U.S. Market.  It is the responsibility of the company seeking to…

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Drug discovery

New Drug Approvals

In the fields of medicinebiotechnology and pharmacologydrug discovery is the process by which new candidate medications are discovered.

Historically, drugs were discovered through identifying the active ingredient from traditional remedies or by serendipitous discovery. Later chemical libraries of synthetic small moleculesnatural products or extracts were screened in intact cells or whole organisms to identify substances that have a desirable therapeutic effect in a process known as classical pharmacology. Sincesequencing of the human genome which allowed rapid cloning and synthesis of large quantities of purified proteins, it has become common practice to use high throughput screening of large compounds libraries against isolated biological targets which are hypothesized to be disease modifying in a process known as reverse pharmacology.

Hits from these screens are then tested in cells and then in animals for efficacy. Even more recently, scientists have been able to…

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FDA Issues Draft Guidance on NCE Exclusivity Determinations

New Drug Approvals

Feb 25, 2014
FDA has released draft guidance on the agency’s interpretation of the five-year new chemical entity (NCE) exclusivity provisions as they apply to certain fixed-combination drug products (fixed-combinations).  The guidance document states that FDA, historically, has said that a fixed-combination was ineligible for five-year NCE exclusivity if it contained a previously approved active moiety, even if the product also contained a new active moiety (i.e., an active moiety that FDA had not previously approved).

The guidance states that because fixed-combinations have become increasingly prevalent in certain therapeutic areas (e.g., cancer, cardiovascular, and infectious disease) and play an important role in optimizing adherence to dosing regimens, FDA is revising their interpretation of the five-year NCE exclusivity provisions “to further incentivize the development of certain fixed-combination products.” FDA intends to apply the new interpretation prospectively. The guidance, however, does not apply to fixed-combination drug products that were approved prior to…

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FDA publishes new Guidance on Validation of Analytical Methods

New Drug Approvals

The FDA has published a new Guidance on the validation of analytical methods which shall replace the 14 years old existing Guideline on the topic. More details about the contents of this highly topical document can be found here.

A new FDA Guidance for Industry entitled “Analytical Procedures and Methods Validation for Drugs and Biologics” was published a few days ago. This Guideline replaces the Guidance for Industry “Analytical Procedures and Methods Validation” from 2000 (this document has never been finalised and has had a draft status 14 years long) and – when finalised – should also replace the “Guidelines for Submitting Samples and Analytical Data for Methods Validation” which came into force in 1987.

Unlike the previous Guideline from 2000, the new document explicitly mentions biologics in its title. The objective of the Guideline is to inform applicants about what data are…

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Regulatory Considerations for Biosimilars

New Drug Approvals

Biological medicines are already becoming an increasingly important part of health care. With patent expiries on originator biological products, biosimilars are also increasingly become a part of this future. In fact, by 2020 twelve of the top-selling biologicals will have lost patent protection, opening up an estimated US$24 billion in EU sales and US$30 billion in US sales.

Biologicals have potential to reach up to 50% share in global pharmaceutical market in the next few years.

India is one of the leading contributors in the world biosimilar market and is the third-largest in the Asia-Pacific region, after Australia and China. India has demonstrated high acceptance of biosimilars, which is reflected in the 40 biologicals marketed in India, of which 25 are biosimilars The Indian biotechnology industry is also gaining momentum, with revenues of over US$4 billion in 2011, and which are projected to reach up to US$580 million by 2012.

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Americas Health Authorities Meeting

Regulatory Affairs in Latin America

On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in Acapulco, Mexico, for a Summit of Health Authorities.

The topics of the agenda were regulation harmonization, reduction of transaction costs, and facilitation of access to drug products and vaccines of high quality and low cost.

Representatives of the American Health Authorities. Photo: COFEPRIS website. Representatives of the American Health Authorities. Photo: COFEPRIS website.

The Health Authorities certified as of Regional Reference currently are those of Mexico (COFEPRIS), Argentina (ANMAT), Colombia (INVIMA), Brazil (ANVISA) and Cuba (CECMED). During the meeting, the representatives of FDA and Health Canada announced their decision to seek the PAHO certification for their own institutions.

The recognition will follow an evaluation of the agencies’ performance of basic functions, recommended by WHO, for ensuring the quality, safety…

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The US FDA has issued full approval for Israeli drugmaker Teva’s Synribo (omacetaxine mepesuccinate)高三尖杉酯碱 for chronic myeloid leukaemia (CML).

New Drug Approvals

Omacetaxine mepesuccinate 高三尖杉酯碱

Alkaloid from Cephalotaxus harringtonia; FDA approved orphan drug status for Ceflatonin in the treatment of chronic myeloid leukemia due to being an inducer of apoptosis in myeloid cells and inhibitor of angiogenesis.
26833-87-4 CAS NO

1-((1S,3aR,14bS)-2-Methoxy-1,5,6,8,9,14b-hexahydro-4H-cyclopenta(a)(1,3)dioxolo(4,5-h)pyrrolo(2,1-b)(3)benzazepin-1-yl) 4-methyl (2R)-2-hydroxy-2-(4-hydroxy-4-methylpentyl)butanedioate

1-((11bS,12S,14aR)-13-methoxy-2,3,5,6,11b,12-hexahydro-1H-[1,3]dioxolo[4′,5′:4,5]benzo[1,2-d]cyclopenta[b]pyrrolo[1,2-a]azepin-12-yl) 4-methyl 2-hydroxy-2-(4-hydroxy-4-methylpentyl)succinate

Also known as:  NSC-141633,

  • BRN 5687925
  • Ceflatonin
  • CGX-635
  • Homoharringtonine
  • Myelostat
  • NSC 141633
  • Omacetaxine mepesuccinate
  • Omapro
  • Synribo
  • UNII-6FG8041S5B
  • 高三尖杉酯碱

CGX-635-14 (formulation), CGX-635, HHT, ZJ-C, Myelostat, Ceflatonin

 USFDA on 26th October 2012  APPROVED

US FDA:    link

Mol. mass545.62 g/mol
Melting Point: 144-146 °C
 FEBRUARY 17, 2014

The US Food and Drug Administration has now issued full approval for Israeli drugmaker Teva’s Synribo (omacetaxine mepesuccinate) for chronic myeloid leukaemia (CML).

Synribo is indicated for adult patients with chronic phase (CP) or accelerated phase (AP) CML with resistance and/or intolerance…

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