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27JAN12 - The Process for Medical Mobile Device Approval

Apple iPhones and BlackBerry devices, along with their apps, have become an important tool for medical personnel working in emergency situations. If you want clearance for your medical mobile device, there are steps you need to take. Click here before 03FEB12 to read our newsletter on this topic.

23JAN12 - FDA Offers Social Media Insight

FDA has released a new draft guidance that offers recommendations to companies wishing to respond to unsolicited requests for off-label information, including requests made via social media websites. Click here before 30JAN12 to read our newsletter on this topic.

16JAN12 - Don't Lose Sleep Over a Drug Recall

While a recall can be a time-consuming and demanding task, there are certain steps to take and help available to get the job done right. Click here before 23JAN12 to read our newsletter on this topic.

18NOV11 - FDA's Strategy to Encourage Pharma Innovation

Due to the concerns about the sustainability of US drug development efforts, FDA has issued a report that outlines steps to ensure biomedical innovation. Click here before 25NOV11 to read our newsletter on this topic.

04NOV11 - Draft Guidance on Classifying Drugs, Devices Questioned

There is concern that a new FDA draft guidance will cause the classification of many products already on the market and classified as medical devices to be reclassified as drugs. Click here before 11NOV11 to read our newsletter on this topic.

21OCT11 - Proposals to Revise FDA's Device Rules

In an effort to protect innovation, the House Energy and Commerce Committee has introduced a series of 10 bills with the goal of reforming the FDA's review process of medical devices. Click here before 28OCT11 to read our newsletter on this topic.

19AUG11 - FDA Reports Focus on Regulatory Collaboration

The U.S. Food and Drug Administration (FDA), in conjunction with its counterparts in Europe and Australia, has released two reports that recap pilot programs that were launched to enhance international regulatory collaboration and help to ensure drug quality and safety on a global level. Click here before 26AUG11 to read our newsletter on this topic.

05AUG11 - Report Identifies FDA's Key Needs and Focus

A report recently released by the FDA from its Center for Drug Evaluation and Research (CDER) identified regulatory needs that will lead strategic planning for FDA in the next several years. Click here before 12AUG11 to read our newsletter on this topic.

29JUL11 - FDA Reaching Out to Small Business

The FDA recently announced plans to implement a program where small business executives would serve as liaisons between the agency and the small business community. Small pharmaceutical and medical device firms are stating that improved interactions between the agency and industry is a top concern. Click here before 05AUG11 to read our newsletter on this topic.

15JUL11 - Ongoing Investigation Into Tainted Heparin

The US Government is expanding its investigation into contaminated heparin from China into the United States market. The US has been working with 10 pharmaceutical companies to see how the contaminated active ingredient got into the US supply chain. Click here before 22JUL11 to read our newsletter on this topic.

08JUL11 - Generic Drugs Digging into the Pet Market

The prescription drug market for pets has been dominated by the big dogs such as Pfizer and Merck. However, a number of other companies are now developing generic pet drugs as many innovator products have recently come off or are soon to come off patent. Click here before 15JUL11 to read our newsletter on this topic.

01JUL11 - FDA's Recent Focus on Prescription Drug Advertising

The overall conclusion of a recent study by the FDA was that the "brief summary" section on printed materials clearly affects consumer understanding of prescription medications. This study was aimed at discovering whether or not consumers truly comprehend information provided on drug labeling and other printed material. Click here before 08JUL11 to read our newsletter on this topic.

24JUN11 - FDA's New Rules for Sunscreen Claims

Food and Drug Administration (FDA) has established new rules for the testing of sunscreens and their ability to block the more dangerous ultraviolet A rays as well as ultraviolet B rays. Beginning next summer, if sunscreens don't protect against both or the SPF is under 15, these products will have to carry a warning. Click here before 01JUL11 to read our newsletter on this topic.

25MAR11 - FDA Bans Imports From Japan

The FDA has just announced a temporary ban on shipments of vegetables, fruits and milk products that originated from areas in Japan that were effected by radiation. This ban is a direct result of the growing concern about Japan's Nuclear Crisis and possible radiation contamination of the surrounding areas. Click here before 25MAR11 to read our newsletter on this topic.

22MAR11 - Medical Manufacturers Losing Millions Due to FDA’s Latest Crackdown

On Wednesday, March 2 2011, the Food and Drug Administration (FDA) announced it is removing approximately 500 unapproved cold and allergy medications from the market as a part of an ongoing crackdown on prescription drug manufactures. Although the FDA requires all new prescription drugs be reviewed and approved prior to launch, thousands of drugs were already on the market before current expectations were in effect. As a result, the FDA has ordered a halt on production and distribution on all products that have not been approved in accordance with current requirements. This culling from the market will cost manufacturers of these products millions. Click here before 29MAR11 to find out steps companies can take to save millions or click here for our official news release on this topic.

11MAR11 - FREE FDA and State Compliance Training Sessions

While ABC offers training courses for a number of "standard industry topics" (e.g. validation programs, CAPA programs, responding for FDA 483s and warning letters, etc.), we want to know what topics you and your company would like to receive training on for FREE. Click here before 18MAR11 to find out how to get FREE training for you and your company or click here for our official news release on the topic.

11JAN11 - Obama Signs Off On Recall Authority and New FDA Fees

Just days ago, President Obama signed off on the Food Safety and Modernization Act (FSMA). Manufacturers/processors of food products need to be prepared for new fees, additional daily operational requirements and significantly increased audits. This new law also is a good indicator of what may be coming down the pike for dietary supplement and other FDA regulated industries. Click here before 11JAN11 to find out more about the new requirements and how ABC recommends management of recalls, one aspect of the law or click here for our news release on the topic.

08OCT10 - Hidden Cost of Manufacturing Medical Device in Foreign Countries

Both US medical device firms and device manufacturers in foreign countries need to understand the true costs of regulatory responsibilities when entering into a business relationship overseas. Who has overall quality and regulatory responsibility for the product is just one issue that is not clear to both domestic and international companies involved in medical device industry. Click here before 05NOV10 to find out who is responsible for what activities and how to ensure a solid understanding among US and foreign firms or click here for our news release on the topic.

FDA is again focusing on both largest and smallest manufacturers and private label distributors of mouthwash and other oral care products. What labeling and other compliance issues is FDA focusing? Click here before 29OCT10 to find out or click here for our news release on the topic.

FDA registration now is difficult enough. With that behind you now, how do you quickly tackle registration for 50 states with differing requirements, so you can legally sell in these states? Click here before 07OCT10 to read the simplified steps for such firms or click here for our news release on the topic.

Annual product updates, facility registration, structured product labeling, and of course 510(k) submissions are all extremely time consuming and difficult tasks for even the most seasoned regulatory experts. These process are even hard for foreign manufacturers trying to market in the USA. Click here before 30SEP10 to read the simplified steps for such firms or click here for an additional article on the topic.

Companies in the food and drug regulated industries try their best to avoid and be prepared for recalls. Click here before 25SEP10 to read how Wright County Egg should be dealing with their massive recall situation or click here for an additional article on the topic