USFDA approves Post – Natal chromosomal variations detection kit

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U.S. Food and Drug Administration authorized for marketing the Affymetrix CytoScan Dx Assay, which can detect chromosomal variations that may be responsible for a child’s developmental delay or intellectual disability. Based on a blood sample, the test can analyze the entire genome at one time and detect large and small chromosomal changes.

According to the National Institutes of Health and the American Academy of Pediatrics, two to three percent of children in the United States have some form of intellectual disability. Many intellectual and developmental disabilities, such as Down syndrome and DiGeorge syndrome, are associated with chromosomal variations.
“This new tool may help in the identification of possible causes of a child’s developmental delay or intellectual disability, allowing health care providers and parents to intervene with appropriate care and support for the child,” said Alberto Gutierrez, Ph.D., director of the Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health. “The FDA’s review of the test provides clinical laboratories with information about the expected performance of the device and the quality of the results.”
The FDA reviewed the Affymetrix CytoScan Dx Assay through its de novo classification process, a regulatory pathway for some novel low-moderate-risk medical devices.
For the de novo petition, the FDA’s review of the CytoScan Dx Assay included an analytical evaluation of the test’s ability to accurately detect numerous chromosomal variations of different types, sizes, and genome locations when compared to several analytically validated test methods.  The FDA found that the CytoScan Dx Assay could analyze a patient’s entire genome and adequately detect chromosome variations in regions of the genome associated with intellectual and developmental disabilities.
Additionally, the agency’s review included a study that compared the performance of the CytoScan Dx Assay to tests that are commonly used for detecting chromosomal variations associated with a developmental delay or intellectual disability. A comparison of test results from 960 blood specimens showed the CytoScan Dx had improved ability over commonly used tests, including karyotyping and FISH chromosomal tests, to detect certain chromosomal abnormalities.
This device should not be used for stand-alone diagnostic purposes, pre-implantation or prenatal testing or screening, population screening, or for the detection of, or screening for acquired or genetic aberrations occurring after birth, such as cancer. The test results should only be used in conjunction with other clinical and diagnostic findings, consistent with professional standards of practice, including confirmation by alternative methods, evaluation of parental samples, clinical genetic evaluation, and counseling as appropriate. Interpretation of test results is intended to be performed only by health care professionals who are board certified in clinical cytogenetics or molecular genetics.
Affymetrix CytoScan Dx Assay is manufactured by Affymetrix, Inc., located in Santa Clara, Calif.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: USFDA


Decorative Contact Lenses: Is Your Vision Worth It?

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Wouldn’t it be cool to have Twilight vampire eyes for Halloween?

Or deep violet eyes to match your purple sweater?

How about your favorite sports team’s logo on your eyes just for fun?

You can have all of these looks with decorative contact lenses (also called fashion contact lenses or color contact lenses, among other names). These lenses don’t correct vision—they just change the appearance of the eye.

But before buying decorative lenses, here’s what you should know:

They are not cosmetics or over-the-counter merchandise. They are medical devices regulated by the Food and Drug Administration (FDA). Places that advertise them as cosmetics or sell them without a prescription are breaking the law.

They are not “one size fits all.” An eye doctor (ophthalmologist or optometrist) must measure each eye to properly fit the lenses and evaluate how your eye responds to contact lens wear. A poor fit can cause serious eye damage, including

  • scratches on the cornea (the clear dome of tissue over the iris – the part of the eye that gives you your eye color)
  • corneal infection (an ulcer on the cornea)
  • conjunctivitis (pink eye)
  • decreased vision
  • blindness
  • Places that sell decorative lenses without a prescription may give you few or no instructions on how to clean and care for your lenses.

Failure to use the proper solution to keep contact lenses clean and moist can lead to infections, says Bernard Lepri, O.D., M.S., M.Ed., an optometrist at FDA. “Bacterial infections can be extremely rapid, result in corneal ulcers, and cause blindness—sometimes within as little as 24 hours if not diagnosed and treated promptly.”

“The problem isn’t with the decorative contacts themselves,” adds Lepri. “It’s the way people use them improperly—without a valid prescription, without the involvement of a qualified eye care professional, or without appropriate follow-up care.”

Where NOT to Buy Contact Lenses

FDA is aware that many places illegally sell decorative contact lenses to consumers without valid prescriptions for as little as $20.

You should never buy lenses from:

  • street vendors
  • salons or beauty supply stores
  • boutiques
  • flea markets
  • novelty stores
  • Halloween stores
  • record or video stores
  • convenience stores
  • beach shops
  • Internet (unless the site requires a prescription)

These are not authorized distributors of contact lenses, which are prescription devices by federal law.

How to Buy Decorative Contact Lenses Safely

Get an eye exam from a licensed eye doctor (ophthalmologist or optometrist), even if you feel your vision is perfect.

Get a valid prescription that includes the brand name, lens measurements, and an expiration date. But don’t expect your eye doctor to prescribe anime, or circle, lenses. These bigger-than-normal lenses that give the wearer a wide-eyed, doll-like look have not been approved by FDA.

Buy the lenses from a seller that requires you to provide a prescription, whether you go in person or shop online.

Follow directions for cleaning, disinfecting, and wearing the lenses, and visit your eye doctor for follow-up eye exams.

See your eye doctor right away if you have signs of possible eye infection:

  • redness
  • eye pain that doesn’t go away after a short time
  • decrease in vision

Source: USFDA

Read the original article here



Pharmacists want CDSCO to clear ambiguities in D&C Act to enable better pharmacy practice

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To enable better pharmacy practice, pharmacists across the country want the Centre to push for immediate corrective measures aimed at clearing the ambiguities in interpretation of drug laws related to retail pharmacy. This demand comes in the wake of growing concern among the retail pharmacists over the lack of clarity in the Act, which is leading to different interpretation of the law, further complicating the matters.

In a detailed representation sent to the Drugs Controller General of India (DCGI), a community pharmacist Raj Vaidya conveyed his concerns affecting from this situation with questions that were very difficult for the pharmacists to answer in the light of these events. Highlighting one of the major concerns affecting the pharmacists, Vaidya pointed out that ever since the Drugs & Cosmetics (D&C) Act & Rules relating to the stocking and sale of medicines at the retail pharmacy and medical store were made many decades ago, significant changes have happened in the types and dosage forms of medicines, packaging of medicines, technology, trade, etc.

“With such changes happening, many of the drug rules do not specifically fit the present situation, and therefore today there arises several ambiguities in the Rules and their interpretation. What happens with this is that the same rule or situation is interpreted differently by different people and many times by different authorities within the drug control department itself. A simplest example is the answer given to the question, whether the pharmacy can cut a strip of tablet or capsule to dispense part of it to the patient,” he pointed out.

He further stressed that while some say that one cannot cut a strip, some say that one has to cut a strip if the patient needs lesser tablets, while some others say that it is the discretion of the pharmacy whether to cut or not to cut a strip.

Such serious ambiguities exist in plenty of other situations in day to day functioning of a retail pharmacy, and only causes confusion amongst the retailers, patients, and also the drug authorities. An expert from this field, Vaidya believes that it is very important that the CDSCO takes up the exercise of going through the entire set of drug laws and rules applicable to retail sale of drugs, and bring about changes in them, so that not only are they in tune with the present day situation, but also take care of several unanswered questions in the existing set of rules. While also ensuring that the rules are written in such a manner that their interpretation is clear and unambiguous.

He elaborated further that there is a long list of situations like indication by labels or other manufacturer packing, other legal aspects related to retail pharmacy, cash memo, dispensing, prescriptions pertaining to retail pharmacy, which either have no answers in the present D&C Act & Rules, or lead to ambiguous answers and interpretations by different persons. “All this results in great difficulties and confusion in the running of a retail pharmacy and medical store, often resulting in arguments with consumers and waste of valuable time. These changes need to be brought about also taking into consideration patient safety and safe use of medicines. Thus we strongly feel that with a view to safeguard the public interest and to ensure better practice, the Centre should bring clear cut rules relating to these and other issues related to retail pharmacy functioning in the country,” he added.

Source: PharmaBiz

Parliamentary panel expresses concern on slow-paced quality control steps for AYUSH drugs

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The Parliamentary Standing Committee on Health has come down heavily on the Department of Ayush for going slow in revising and implementing the centrally sponsored scheme for improving the quality of Ayurveda, Siddha, Unani and Homoeopathic (ASU&H) drugs.

“The Committee is not happy with the snail’s pace of the progress made in the matter. It is already the second year of the 12th Plan and if the Department is still in the process of revising the Centrally Sponsored Scheme for supporting State Drug Testing Laboratories and Pharmacies, it is a sad commentary on its decision making process,” the recent report of the panel said.

“The Committee is at a loss to understand as to how the requirements of quality control will be met if the revision of the Scheme is delayed inordinately. The Committee, therefore, recommends to quickly finalize Scheme and implement the same,” it said.

The panel had in its earlier report recommended revision of the quality control scheme at the earliest. “The Committee observes that there is a separate chapter IV A in the Drugs and Cosmetics Act 1940 which regulates the manufacture and sale of ASU&H drugs. Since the enforcement of provisions of Drugs and Cosmetics Act and Rules made there under is under the purview of State Drug Licensing and Drug Control Authorities, the state drugs regulatory framework has a crucial role to play in ensuring safety and quality of ASU&H drugs. It is in this context that strengthening of State Drug Testing Laboratories which are facing infrastructure constraints, and shortage of manpower, assume added significance,” its earlier report had said.

Detailing the actions taken on the recommendations, the Department said an evaluation was made on the scheme by an outside agency and the report was received. “The Department has initiated action to revise the scheme with enhanced scope and suitable modification of funding pattern in the 12th Plan. It is intended to make the scheme broadbased for covering priority requirements of quality control of ASU&H drugs including improvement of infrastructural and functional capacities of State Drug Testing Laboratories,” the department said.

Source : PharmaBiz


GVK BIO to acquire Aragen Bioscience, Inc.

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Asia’s leading small-molecule contract research organization (CRO), GVK BIO and Aragen Bioscience, Inc., a privately held US based, pre-clinical CRO specializing in high-value biologics services, have entered into an agreement to acquire the capital stock of Aragen Bioscience. GVK BIO has established itself as a pre-eminent small molecule service provider. This is GVK BIO’s first international acquisition; the financial details were not disclosed.

This deal enables GVK BIO to expand its service offering to a broader base of organizations and gives GVK BIO expertise in biologics services and a significant US presence. The acquisition provides Aragen with the ability to expand its service offerings, access to GVK BIO’s global sales force and access to new markets.

The acquisition of Aragen Bioscience provides GVK BIO with world-class expertise in large molecule R&D services and a unique and extensive set of high-content biological services. Combined with GVK BIO’s established small molecule discovery and development capabilities, this expansion uniquely position GVK BIO as a leading provider of integrated R&D services across both large and small molecule platforms and provides a base for further expansion.

D S Brar, chairman, GVK BIO, said,“As an increasing number of biotech and pharmaceutical companies focus on protein based therapeutics and biosimilars, the acquisition of Aragen Bioscience will strategically enhance GVK BIO’s ability to offer high quality R&D services to the industry from a seamless integrated platform.”

“Aragen’s scientific excellence and expertise in large-molecule R&D services combined with GVK BIO’s scale, resources, and global reach will create significant synergies for both companies” stated Rick Srigley, president & CEO, Aragen Bioscience.

GVK BIO provides a broad spectrum of integrated services, across the R&D and manufacturing value chain with a focus on speed and quality. GVK BIO capabilities include discovery research, discovery services, clinical development, contract manufacturing, formulations and informatics. GVK BIO’s 2400 employees serve a diverse and global customer base of more than 300 satisfied customers.

Aragen Bioscience, Inc. is a privately held contract research organization with offices and laboratories in the San Francisco Bay Area. Aragen Bioscience offers a diverse set of services for the discovery, characterization, activity assessment and early development of biologic and diagnostic products.

Source : PharmaBiz