• Regulatory NewsRegulatory News

    Generic Drugs Should Look Similar to the Drugs They Reference, FDA Says

    The US Food and Drug Administration (FDA) is recommending drugs made by generic manufacturers closely mimic the physical attributes, including the size, shape and color, of the drugs they reference. Background When FDA approves an abbreviated new drug application (ANDA), it does so primarily on the basis of a drug's bioequivalence to the Reference Listed Drug (RLD), the drug to which the generic is compared. Data must show a drug contains the same active ingredient, in ...
  • Regulatory NewsRegulatory News

    FDA to Study Effect of Generic Drug Appearance on Patient Adherence

    Does the color, shape or size of a generic drug affect how willing patients are to adhere to existing treatment regimens? The US Food and Drug Administration (FDA) wants to know. Background FDA has long been interested in the physical attributes of drugs, and in particular generic drug products. In December 2013, for example, it released a new guidance document, Size, Shape, and Other Physical Attributes of Generic Tablets and Capsules . In it, FDA explained tha...
  • FDA to Generic Sponsors: Physical Attributes Should be Similar, if not the Same

    When a generic drug seeks approval from the US Food and Drug Administration (FDA) under Section 505(j) of the Federal Food, Drug and Cosmetic Act (FD&C Act) , the majority of FDA's review time is spent assessing whether the drug is chemically equivalent to its reference listed drug (RLD). Background But, as FDA notes in a newly released draft guidance document, physical attributes can have a meaningful impact on safety and efficacy as well, and manufacturers need t...
  • Study: Many Clinical Trials Small, of Poor Quality

    Amidst an explosion in the number of clinical trials registered with US regulatory authorities, a new study analyzing clinical trials conducted in the US has found most of them to be relatively small and of inconsistent-and often poor-quality. The study, Characteristics of Clinical Trials Registered in ClinicalTrials.gov, 2007-2010 , was published in the Journal of the American Medical Association (JAMA) on 2 May 2012. "Clinical trials registered in ClinicalTrials.go...
  • FDA Provides New Guidance for Promotional Labeling and Advertising

    The US Food and Drug Administration (FDA) released a new guidance for industry on 24 January on the placement, size and prominence of a product name in promotional labeling and advertising. The final guidance, Product Name Placement, Size, and Prominence in Advertising and Promotional Labeling , "is intended to clarify the requirements" for prescription medicinal products for both humans and animals. FDA notes that the proper use of a product's name is important in e...
  • FDA: Tablet Size Matters for Generics

    The US Food and Drug Administration (FDA) is warning generics manufacturers with pending Abbreviated New Drug Applications (ANDAs) that their products must adhere to the Reference Listed Drugs' (RLD) tablet size, writes Kurt Karst at FDA Law Blog . The Office of Generic Drugs (OGD) wrote to several manufacturers that the non-uniform, larger tablets represented choking hazards, efficacy issues due to patient inability or unwillingness to swallow the tablet, and the p...