Compliance Resources to Help you Stay Current

Non-prescription (OTC) drugs marketed without an approved application are also subject to adverse event reporting requirements, under section 760 of the Federal Food, Drug, and Cosmetic Act. A report of each adverse drug experience which is both serious and unexpected must be made to the Agency, as soon as possible, but no later than 15 days, after receiving information about the event.

An original drug manufacturer seeking new drug approval from the FDA is responsible for accurately and adequately labeling the new drug. A manufacturer of a generic drug is only responsible for making sure its warning label is the same as the reference drug. This has led to an outcry from patients and drug manufacturers as generics makers cannot be held legally responsible for any product defects. Both groups are demanding a change in current generics warning label regulations by the FDA.

Drug shortage in the US is going global, as the pharmaceutical industry is increasingly globalised, shortages in one country will affect others. In 2011, according to FDA, as many as 250 drug shortages have been traced, and a total of 195 drug shortages were prevented, as the Agency has taken proactive steps needed to increase available supply for patients in the U.S.

On Feb 28 2012, the FDA released new draft guidance on safety changes for widely used cholesterol – lowering or statin drugs. These regulations aim to educate, update health care professionals and patients about the health benefits as well as risks associated with these drugs.

On February 9, 2012, the FDA released draft guidelines about quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and are based on key scientific and regulatory factors which should be considered for submission of applications for bio-similar products to the FDA.

On February 9, 2012, the U.S FDA released draft guidelines about scientific and quality considerations in bio-similar product development. These guidelines provide insight into the procedures which are required to show high similarity with an FDA-licensed biological product and provide an overview of FDA’s approach in determining bio-similarity of a biologic product.

On December 27, 2011, the FDA released new draft guidance on 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications. The guidance aims to explain the decision-making process of FDA for determining substantial equivalence and provides additional details about the regulations, strategies, and norms upon which the FDA’s review of the 510(k) application is based. The guidance also provides information about new policies regarding Special 510(k) and Abbreviated 510(k) submissions to FDA.

The American Red Cross, which supplies 40 – 45% of donated blood in the U.S., was recently fined by the FDA for substandard and unsafe practices on blood management and for failing to rectify these violations. This article details the reasons behind the FDA fine and the laws that were violated.

No. The FDA is trying to increase the representation of women in clinical studies of medical devices. According to the FDA’s recently issued draft guidance on Evaluation of Sex Differences in Medical Device Clinical Studies, medical device clinical trial sponsors can create tailored communication strategies (as used in the Women’s Health Initiative study) for study recruitment, informed consent documents and patient labeling.

The guidance also recommends that device manufacturers and developers, where appropriate, can target investigational sites where recruitment of women can be more easily facilitated. These investigational sites include women’s clinics.

Read an overview and summary of recommendations of the new FDA draft guidance aimed at increasing the representation of women in device clinical studies.
 

The FDA has issued a draft guidance that aims at increasing the representation of women in medical device clinical trials. Aimed at medical device manufacturers and developers, the guidance outlines agency recommendations for designing and conducting device clinical studies that may enhance the enrollment of women in such studies, if appropriate.

This article gives an overview and summary of recommendations included in this FDA draft guidance.
 

The Physician Payment Sunshine Act was passed in 2010 as part of President Barack Obama’s legislative agenda to overhaul healthcare. The Centers for Medicine and Medicaid Services (CMS) was tasked with the drafting of the rules to enforce the Act’s requirements. CMS published its proposed rule in December, 2011.

This article gives a brief overview of the proposed rule and its requirements.
 

No – not all medical device malfunctions have to be reported by a manufacturer. If they are not likely to result in death, serious injury or other significant adverse event experiences, malfunctions need not be reported.

A malfunction that is found or corrected during routine service of the device must be reported if its recurrence is likely to cause or contribute to death or serious injury.

If any of the following happens, then a malfunction is considered reportable:

1. The chance of death or serious injury occurring as a result of a recurrence of the malfunction is not remote;
2. The malfunction affects the device in a catastrophic manner and may lead to the death or serious injury of the patient using it;
3. It causes the device to fail to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness. This in turn can contribute to a death or serious injury, or other significant adverse device experiences. The essential function of a device refers not only to the device's labeled use, but for any use widely prescribed in medical practice;
4. It involves an implant malfunction that would be likely to cause or contribute to death or serious injury, regardless of how the device is used;
5. There is malfunction in the device considered life-supporting or life-sustaining, and essential to maintaining human life; or
6. The manufacturer is required to take action under section 518 or 519(f) of the FD&C Act as a result of the malfunction of the device.

Read the best practices that medical device manufacturers must follow in the medical device reporting (MDR) process.

Yes – as shown by the Department of Health and Human Services’ (HHS) overruling of the FDA’s approval of the sale of Plan B contraceptive pill to adolescents without a prescription.

This, however, is the first time in history that a senior US government official overruled the FDA’s approval for a drug. Until this, the FDA’s approval for a drug was considered final. The decision by Kathleen Sibelius, the Secretary of the HHS, has set a historical, and controversial, precedent. Many observers (from the industry, scientific and healthcare fields) feel that this has diminished the FDA’s scientific drug approval process. Critics of the decision say that political considerations have trumped scientific decision-making.
 

No. The FDA's Abbreviated New Drug Application or ANDA process, used by generic manufacturers to apply for approval for their copies of drugs, does not require the company to repeat costly animal and clinical research on ingredients or dosage forms already approved for safety and effectiveness.

Instead, generic manufacturers need to show that their product is bioequivalent or performs in the same manner as the original, innovator drug.

Bioequivalence can be demonstrated by measuring the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy, volunteers.

In late November 2011, Ranbaxy won approval from the FDA to start selling its generic version of Pfizer’s cholesterol drug, Lipitor. The approval was given as Pfizer’s patent for the drug had expired.

This article explains how the FDA approves generic drugs and how Pfizer is trying to lessen the impact of the Lipitor patent expiry.

Yes – a scanned paper signature is considered an electronic signature as regulations state that an electronic record is considered signed and approved by the signatory if there’s a digital scan of the signature, symbol, digital certificate or corporate logo.

Electronic signatures can be constructed in a number of different ways.

According to the Electronic Signatures in Global and National Commerce (ESIGN) Act, an electronic signature means “an electronic sound, symbol, or process, attached to or logically associated with a contract or other record and executed or adopted by a person with the intent to sign the record.”

For 21 CFR Part 11 compliance, an electronic record is considered signed if there’s a digital scan of the provider’s signature or a digital certificate or a corporate logo – objects which the parties understand is tangible evidence of the signatory’s approval/agreement with the record. The regulation itself states that:

“Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature.”

Read the FDA’s guidance to industry on 21 CFR Part 11 compliance

The FDA has issued a draft guidance document on how manufacturers should present risk information in promotional material and ads for prescription drugs and medical devices. It describes the factors that the agency takes into consideration when evaluating ads and promotional labeling for prescription drugs and medical devices.

This article gives an overview and summary of the recommendations included in the FDA guidance.

In June 2011, the Food and Drug Administration issued draft guidance on using human factors and usability engineering to optimize medical device design. The aim of this guidance document is to help the medical device industry in conducting appropriate human factors testing and identifying device features that manufacturers should optimize throughout the total product life cycle.

This article gives a brief overview and summary of recommendations contained in this draft guidance.
 

In October 2011, the FDA issued final guidance on Warnings and Precautions, Contraindications, and Boxed Warning Sections of Labeling for Prescription Drugs and Biological Products. The aim of the guidance is to help ensure that labeling is clear, useful, informative, and to the extent possible, consistent in content and format.

This article gives a brief overview and summary of the recommendations contained in the guidance.
 

The Food Safety Modernization Act (FSMA) of 2011 not only formulated regulations to protect consumers by ensuring safety in the manufacture and production of food, but also includes statutes to protect employees who turn whistleblowers.

This article gives a brief overview and summary of these provisions.