All Blog Posts Tagged 'FDA' (145)

After carrying out the initial preclinical studies, drug manufacturers need to implement cGMP quality systems and risk management approaches during commercial development and operations in order to be able to meet the requirements of the FDA’s current Good Manufacturing Practice (cGMP), which are contained in and are governed by regulations 21 CFR parts 210 and 211.

The FDA’s guidance on cGMP quality systems and risk management approaches is meant to help drug manufacturers implement…

Preparing premarket submissions that win regulatory approval is a complex task, even for the most seasoned professional in the medical devices industry. This is because of the highly stringent nature of the regulatory approval pathways, namely the Premarket Approval (PMA) process and FDA regulatory 510(k) clearance.

What makes preparing premarket…

Any company or individual that is required to submit IRS Form 1099 can avail a facility the Internal Revenue Service (IRS) has: the Taxpayer Identification Number (TIN) matching. This matching or likeness is among an assortment of e-services that gives what are called “authorized payers” the opportunity to match and state their own 1099 payee information with the pertinent records from the IRS. The TIN matching is a pre-filing facility, since it is done before an entity files information…

The in-vitro diagnostics (IVD) market is a diverse and fast changing one. Of late, one of the significant changes that happened to it resulted from the passage of the Final Rule. As part of the Affordable Care Act (ACA) or Obamacare, the Centers for Medicare and Medicaid Services (CMS) introduced the Final Rule to the 2014 Protecting Access to Medicare Act (PAMA) in mid-2016, which is set to make a significant impact on the in-vitro diagnostics market by delaying implementation of…

Statistics for the non-statistician: Isn't this some kind of a contradiction in terms? Why does a non-statistician need to rake his head over statistics? Is statistics a life skill or a lifesaving one? If it is not, why is statistics for the non-statistician necessary? At first glance, statistics for the non-statistician may appear unnecessary and redundant,…

ISO 14971:2012 and IEC 62304:2006 are related but different global standards for risk management pertaining to software used in medical devices. Judicious application of these two standards is the way to go for medical device companies.

ISO 14971 and IEC 62304:2006 are global standards that govern risk management and lay out regulations and guidelines for…

Software Validation Process for 21 CFR Part 11 is all about authenticity and integrity of electronic signatures and records. Care should be taken to avoid confusion and get validation right.

The FDA’s Code of Federal Regulations (CFR) is a collection of laws that regulate the various government agencies. Different titles of the CFR govern respective regulated…

Statistical power may be understood as being an indicator of the ability of a test of significance to spot a practical difference, such as the one between the averages of two products that are being compared. In this context, a low power typically means that the sample sizes in the study are too small. Conclusion of what is “non-significant” is justifiably questionable when it is arrived at without an analysis of statistical power. For this reason, unless power is high, a study may be doomed…

In a broad sense, GMPs refer to good manufacturing practices in any field. The main intention of these GMPs is that they enable industries to perform the required practices needed for complying with guidelines set out by the regulatory authorities. GMP guidelines are issued by regulatory authorities all around the world, mainly in the US, Canada, the countries of Europe and many others.

The ambit…

FDA Code of Federal Regulations (CFR) is a huge sea of regulations that the FDA has created for regulating all products that come under its purview of regulation. The FDA codes of federal regulations are numbered and cover all products, processes and the activities that go into their creation.

The FDA Code of Federal Regulations is a compendium of codified general and permanent rules the federal…

Good Documentation Practice (GDP) constitutes the backbone of any GxP environment. Not only is GDP a sound business practice; it is also an FDA requirement. This being the case, it is absolutely essential for FDA-regulated organizations to get their GDP right. An organization that does not get its GDP right risks facing a number of consequences.

Today’s regulatory requirements are stricter than ever before. In this environment of very rigid regulatory environment;…

Although unfortunate; it is true that those who work in water systems design them keeping obsolete concepts in mind. Why this happens is that the water systems organization is reluctant to be open-minded enough to update its water systems from time to time. The result is that the water systems get built on a shaky foundation, making them fundamentally weak.

Myths are the backbone of water systems failures

An additional problem faced by most microbial monitoring…