What are the FDA's Process Validation requirements?

November 29, 2018

Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.

What is the FDA's Compassionate Use program?

September 11, 2018

The FDA has a Compassionate Drug Use program that is aimed at facilitating the administration of lifesaving drugs to patients in need of them by sidestepping the process of drug approval. In other words, when a patient is in a critical, life-threatening condition and there is no established or approved drug or therapy available in the market for it, the FDA can approve the administration of these tested, but unapproved drugs even if they have not gone through the usual approval process.

The FDA's position on kratom

September 10, 2018

Kratom is an opioid that belongs to the coffee family. Native to some South Asian countries such as Thailand, Malaysia, Papua New Guinea and Indonesia; kratom is consumed as a drink in those regions, where it has a cultural and recreational association. It is primarily used as a sedative and stimulant whose effect starts from five to 15 minutes of ingestion and may last from two to 10 hours.

FDA issues statement as valsartan recalls grow

September 08, 2018

The joint statement by FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research, in late August, is the latest update in a series of developments concerning the high blood pressure and heart failure drug, valsartan, an angiotensin II receptor blocker (ARB) consumed by millions of Americans. This statement detailed the risks of consuming the drug and explained its investigations into its continued use.

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The FDA’s updated approach for including added sugar information on the Nutrition Facts labels of pure maple syrup and honey

September 07, 2018

FDA Commissioner, Scott Gottlieb, has announced a major overhaul of the FDA’s update to the Nutrition Facts label on products. This overhaul, the first in nearly twenty years, is aimed at empowering consumers by furnishing information on Nutrition Facts labels pure maple syrup and honey that ensures greater accuracy and is more science-based. With this, the FDA wants to help consumers make more informed and healthier choices.

FDA approves new dosage strength of opioid dependence drug, buprenorphine

September 05, 2018

In yet another attempt aimed at improving Medication Assisted Treatments (MAT) for opioid dependence, the FDA has approved a new strength for the maintenance treatment of opioid dependence, Cassipa (buprenorphine and naloxone) sublingual film (to be applied under the tongue) from Teva Pharmaceuticals. The new 16 mg strength will supplement existing doses of both branded and generic versions of this drug.

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Statement from the FDA Commissioner on new steps to help ensure the quality of and preserve access to compounded drugs by pursuing closer collaboration with states

September 03, 2018

The FDA has stressed the need for closer collaboration with states on taking steps to reduce the risks associated with compounded drugs, even as it seeks to ensure complete access to them. Towards fostering this collaboration, the FDA issued a set of revised draft memoranda of understanding (MOU) between it and the states.

FDA announces voluntary recall of Montelukast tablets by Camber Pharmaceuticals due to incorrect drug in bottles

September 02, 2018

What happens when your doctor prescribes a drug for treating wheezing, chest tightness, breathing difficulty and cough induced by asthma in good faith, and you, in equally good faith, take those medicines, except that what you took were medicines meant for treating high blood pressure? It is neither your mistake nor the doctor’s. It is a case of the pharmaceutical company mixing up drugs.

FDA helps facilitate trade between U.S. and foreign trading partners with new export certification program for food

September 01, 2018

The FDA has taken another concrete step towards facilitating exports to countries from the US. On August 31, the FDA announced a new export certification program for certain FDA-regulated food products that it will assess and permit to export. It will also assess and fix the fees from such companies that will be permitted to export to other markets from the US.

FDA takes action against 21 websites marketing unapproved opioids as part of agency’s effort to target illegal online sales

September 01, 2018

Taking a tough line against websites marketing unapproved opioids online, the FDA has issued Warning Letters against four online networks that were managing as many as 21 websites that it found to be marketing illicit opioids, including the highly dangerous tramadol. The Warning Letter demands that this group of websites stop the online sale of these drugs immediately and reply to the agency within 10 working days. The four companies that have been served this notice are CoinRX, MedInc.biz, PharmacyAffiliates.org and PharmaMedics.

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FDA alerts consumers, pet owners not to use products manufactured by King Bio, including Dr. King’s label, homeopathic drug and pet products

August 30, 2018

The FDA has warned consumers to stop using human and animal drug products manufactured by Asheville, NC-based King Bio Inc. immediately. This follows the agency’s detection of high levels of microbial contamination at King Bio’s manufacturing facility. King Bio Inc. manufacturers homeopathic products for a number of ailments including colds, chickenpox, learning deficiencies, appetite loss, warts and indigestion, in addition to a variety of pet products.

Companies cease sales of e-liquids with labeling or advertising that resembled kid-friendly foods following FDA, FTC warnings

August 30, 2018

The warning that the FDA had issued in May this year against as many as 17 companies that were selling e-liquids that carried labeling or advertising that resembled kid-friendly foods has paid off. On August 23, 2018, the agency announced that all these manufacturers have stopped selling these friendly food products, which typically included kid- such as juice boxes or candy, or food items such as cookies.

FDA Approves First Drug for Neurotrophic Keratitis, a Rare Eye Disease

August 27, 2018

The FDA’s approval of Oxervate, a drug used to treat Neurotrophic Keratitis, on Aug. 22, 2018 has come as a relief for many people with this condition. Neurotrophic Keratitis, a degenerative disorder of the eye, afflicts only one in 2000 people, but its consequences can be deadly for those who suffer from it:

FDA Regulatory and Compliance

June 20, 2018

Following FDA regulatory requirements is of vital importance to any organization that is regulated by this regulatory agency. FDA regulatory compliance is a very vast area that encompasses all activities in the food, pharmaceutical, healthcare, medical devices, biotechnology, cosmetics, veterinary, in-vitro diagnostics and food supplements industries. Thus, FDA regulatory compliance is something that covers almost any area of activity of the life sciences that one can think of.

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What is Regulatory Compliance? And Why it is Important in Pharmaceutical, Medical Device and Healthcare Industries?

June 14, 2018

Understanding regulatory compliance and its importance in the pharmaceutical, medical device and healthcare industries is very crucial for regulatory professionals, and anyone connected with these industries, for a number of reasons.

What is Compliance and Risk Management?

June 1, 2018

All organizations and businesses face risks of many kinds and varying degrees. A risk, as is commonly understood, is the likeliness of a negative result from an activity. From this definition, there is a risk from almost any business activity, because risk is the probability that a negative consequence, intended or unintended, could arise from a situation or an action. Likewise, businesses also understand and live with the fact that risk is inherent into simply anything that a business carries out, be it small or big. This is what risk management is essentially about.

Candidates should ask future employers smart questions at the time of interview

February 16, 2018

A candidate asking questions? Is this a typo or some kind of misinformation? Not really. Interviewing for a job is not a one-way street. Yes, as a candidate, you are expected to answer questions most of the time, but there is a stage when the interviewer would want to know if you have any questions.

Augmented Reality (AR) has enormous uses in healthcare

January 15, 2018

Disruptive technologies have been a regular feature of our world. Every now and then, a new wave comes and replaces existing technologies, or makes them irrelevant. One big technology that we could see transforming many sectors is Augmented Reality (AR). In short and simple terms, AR is a kind of technology that enhances the feel of images by using an overlapping method, by which the user can see surreal or augmented images of an event.

Trends that could change the face of GRC

October 22, 2017

Governance, risk and compliance has been around for a while now. A canopy term that includes the principal functions of governance, risk management and regulatory compliance; this term has come a long way from its inception in about the early 2000's. On the face of it, it continues to be concerned with its core function of assessing risk management in an organization's

Will smart devices be the smartphones of the medical device industry?

October 14, 2017

This is how the current-day situation of administering medical care runs: in the event of a medical need, the patient or someone attached to her is expected to sense the difficulty and call up the medical center to which the patient is attached. Help arrives after this is done. The medical practitioner may come over and attend to the patient at her location if the situation permits.

Dramatic changes expected into medical device regulations

June 15, 2017

A slew of updates to existing medical device and diagnostics (MD & D) regulations is on the cards. Medical device and diagnostics is a field that keeps changing every now and then. But what is different this time is that the industry is up against a series of updates, not just from one regulatory agency, but from a multitude of agencies and standards:

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