India’s Central Drugs Standard Control Organization (CDSCO) implemented the New Drugs and Clinical Trials Rules in 2019 to expedite the drug development and approval processes. This article provides an overview of those processes; explains the rule-specific terminology, such as the definitions of “drug” and “new drug” under Indian law; and outlines strategies for speeding up the approval processes and optimizing registration of prescription medicines in India.   Keywo...

Though the World Health Organization declared smallpox eradicated in 1980, FDA has approved Tembexa (Chimerix,brincidofovir) as a treatment for the contagious, deadly disease caused by the variola virus.   The 4 June announcement of Tembexa’s approval noted that smallpox drug development is “an important component of the US medical countermeasures response,” since the federal government has significant concerns about the virus’ potential use as a bioweapon. Tembexa was...

The US Department of Health and Human Services (HHS) is postponing the implementation of a controversial Trump era rule that would have required the department to review thousands of its regulations while the rule undergoes judicial review.   The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) was first proposed in November 2020 and finalized on 19 January 2021, one day before President Joe Biden’s inauguration. At its core, the rule would sunset m...

With just days remaining before the transition to a new administration, the Department of Health and Human Services (HHS) is pushing through policies that could impact the US Food and Drug Administration’s (FDA) regulatory oversight.   Last week, HHS announced it had finalized a rule that would cause its regulations to expire if they are not reviewed every 10 years, with some exceptions provided for medical device-specific regulations, food standards and over-the-cou...

The US Food and Drug Administration (FDA) issued a proposed rule on Monday to remove the required testing method to detect the presence of Mycoplasma because FDA said the regulation is restrictive in that it identifies only one test method to be used even though other methods may be appropriate. The proposed rule seeks to remove the testing method for Mycoplasma detection in virus harvest pools and control fluid pools of live and inactivated virus vaccines produced ...

The US Food and Drug Administration (FDA) on Friday proposed to amend and repeal parts of the current radiological health regulations regarding certain recommendations, including radiation protection during medical procedures and performance standards for diagnostic x-ray systems. The action sought via the new proposed rule also covers recommendations under the radiological health regulations on diagnostic x-ray systems’ major components, laser products, ultrasonic ther...

Trade associations representing the medical device and clinical research industries, as well as the nonprofit public advocacy organization Public Citizen, are calling for the US Food and Drug Administration (FDA) to clarify provisions of its proposed rule for institutional review boards (IRBs) to waive or alter requirements for obtaining informed consent for certain clinical trials involving minimal risk to participants.   Background   Under current FDA regulations...

Confusion and concerns over portions of a tobacco-related final rule have pushed the US Food and Drug Administration (FDA) to delay indefinitely the implementation of the sections dealing with the types of evidence FDA may consider to determine how a manufacturer intends for its medical product to be used. "This is a determination that can have significant implications for, among other things, how manufacturers communicate about and promote their products. How we determi...

The US Food and Drug Administration (FDA) on Thursday issued draft guidance providing recommendations on completing certain portions of the Highlights section of labeling for prescription drugs and biologics. Specifically, the guidance details the content and format of the Product Title and Initial US Approval subsections within the Highlights of Prescribing Information for newly approved drugs and drugs with labels being revised. In 2006, FDA's final rule on the conten...

Almost a year ago, the National Institutes of Health (NIH) made effective a new policy to better disseminate information from NIH-funded clinical trials through ClinicalTrials.gov, and the agency says that so far, it’s seen some improvements. Back in 2007, section 801 of the Food and Drug Administration Amendments Act (FDAAA 801) established a requirement that "applicable clinical trials" must be registered and information must be submitted to Clinicaltrials.gov. ...

California's Supreme Court on Thursday ruled against Novartis in a decision that could have wider implications for whether brand-name or generic drugmakers should be held liable for warning consumers of risks in their drug labels. In a departure from other recent rulings, the highest California court found that a brand-name drug manufacturer's duty to warn consumers does extend to a generic, but only because federal regulations currently require generic drugs to carr...

The US Food and Drug Administration (FDA) on Tuesday finalized a rule barring the use of 24 active ingredients, including triclosan, from use in over-the-counter (OTC) antiseptic washes and rubs such as hand washes and surgical hand scrubs used in health care settings. The rule was first proposed in 2015 , and finalizes a 1994 tentative final monograph for OTC antiseptics as amended by the 2015 proposed rule. "Ensuring the safety and effectiveness of over-the-counter h...