• Regulatory NewsRegulatory News

    FDA to Require Electronic Submission of New Drug, Biologic Files in Next Two Years

    Within two years, the US Food and Drug Administration (FDA) will require all new drug and biological product submissions to be sent electronically, the regulator announced this week. Background FDA has received electronic submissions from drug companies since at least 2003, when it adopted the International Conference on Harmonisation's (ICH) electronic common technical document (eCTD). The submission standard is used by many of the world's top regulatory bodies, incl...
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    An Increasing Number of Companies Are Using a Once-Obscure FDA Drug Approval Pathway

    Companies are increasingly using a lesser-known regulatory pathway to get new doses, formulations or combinations of drugs approved by the US Food and Drug Administration (FDA), a review by Thompson Reuters has found. Background In the US, pharmaceutical products are in general approved in one of three ways: A drug never before approved by FDA for a specific condition is approved using a New Drug Application (NDA) through the 505(b)(1) pathway A generic drug refere...
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    Group Asks FDA for More Warning Information on Dietary Supplement Labels

    A public health group is calling on the US Food and Drug Administration (FDA) change the warning labels on all herbal and dietary supplements to include more information about how the products might cause side effects, interact with pharmaceuticals and affect pregnant women. Background The call, made in a new Citizen Petition by the group Pharmacists Planning Service (PPS), comes after a recent investigation by the New York Attorney General found that some dietary a...
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    FDA Cracking Down on Attempts to Delay Entry of Generic Drugs, Data Show

    A new report issued by the US Food and Drug Administration (FDA) on the use of petitions meant to delay or prevent the entry of new generic drugs shows that the agency is denying those petitions in record numbers, even as regulators say its authority to dispose of them more easily is lacking. Background FDA, like any other federal agency, takes actions in response to a wide range of factors. It may, for example, implement a new policy at the explicit direction of ...
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    Company, Warned by FDA Over Improper Marketing, Petitions Regulators for Redress

    Most Warning Letters sent by the US Food and Drug Administration (FDA) are met by their recipients with a sense of loathing and urgency. A failure to respond to a letter quickly and appropriately can lead to major sanctions against a company, to say nothing of the damage a bungled response can do to a company's reputation. But one company, cited by FDA in September 2014 Warning Letter alleging that it improperly marketed a product to treat Ebola, is fighting back in an u...
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    FDA Facility Held Unknown Vials of Smallpox, Dengue, Q Fever and Other Deadly Diseases

    The US Food and Drug Administration (FDA), just days after announcing that it had found decades-old vials of variola —the virus which causes smallpox—inside a storage facility it owned, has announced that the deadly virus wasn't the only dangerous substance it found during a cleanout of the facility last month. Dangerous Substances In a statement released to the press on 16 July 2014, the agency confirmed that it found hundreds—327 to be exact— of "carefully packaged v...
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    Public Citizen Again Calls for Ban on Diabetes Drug Victoza

    A prominent consumer watchdog group is calling on the US Food and Drug Administration (FDA) to withdraw its approval of the diabetes drug Victoza (liraglutide), which it says is linked to acute pancreatitis and several deaths. Background Victoza was approved by FDA in 2010 as a once-daily injectable treatment for Type 2 diabetes. The drug is an incretin mimetic drug known as a glucon-like peptide-1 (GLP-1) receptor agonist. At the time of its approval, FDA noted...
  • FDA Says Abuse-Deterrence Equivalence Guidance is Under Development

    The US Food and Drug Administration (FDA) has announced it intends to issue a guidance document regarding the equivalence of abuse-deterrent qualities between generic and branded versions of Purdue Pharma's Oxycontin, laying a pathway to approval for future generic market entrants-and perhaps other types of drugs as well. Background In April 2013, FDA announced that it had determined that an original, non-abuse-deterrent version of Oxycontin (oxycodone hydrochloride) ...
  • FDA Looks to Close Loophole That Could Delay Approval of Biosimilars

    US regulators on Monday indicated that they are moving to close a regulatory loophole identified by legislators in 2012 that could prevent a biosimilar product from obtaining timely approval. Background: FDAAA In 2007, legislators passed into law the Food and Drug Administration Amendments Act (FDAAA) , which contained a provision-Title IX, Section 914-that allows the US Food and Drug Administration (FDA) to disregard certain Citizen Petitions if their sole intent is...
  • J&J Petition Claims FDA Decision Meant to Ease Drug Shortages Puts Some Future Patients at Risk

    Drug shortages have been a recurring problem in the US thanks to a combination of market factors, regulatory decisions made by the US Food and Drug Administration (FDA) and manufacturing problems experienced by companies. So in 2012, when Johnson & Johnson's oncology drug Doxil (doxorubicin hydrochloride liposome injection, NDA # 050718 ) started experiencing shortages, FDA unveiled an unusual plan . It would allow a similar drug, Lipodox (ANDA # 203263 ), made by ...
  • Consumer Group Calls for New Warnings for Low-T Products, Delay of Endo's Aveed

    Less than a month after US regulators issued a preliminary warning about the cardiovascular risks associated with products intended to treat low testosterone levels in men, a prominent consumer advocacy group is calling on the US Food and Drug Administration (FDA) to add more serious warnings to the products. Background FDA's review of the products, commonly known as "low-T" drugs, was triggered by two separate studies. The studies, in the  Journal of the American...
  • Regulators Ask: Is FDA's Generic Drug Submission Process Broken?

    Can the quality of generic drug applications to the US Food and Drug Administration (FDA) be improved, and if so, what can regulators do to improve it? So asks FDA in a new Federal Register notice published on 22 January 2014, in which the agency notes that the completeness and quality of abbreviated new drug applications (ANDA)-the application used by generic drugs-has left something to be desired by regulators as of late. Common Problems "The Office of Generic Drug...