• Regulatory NewsRegulatory News

    For gene therapies, FDA drafts trial guidance, finalizes "sameness" for orphan exclusivity

      A new draft guidance from the US Food and Drug Administration (FDA) gives cell and gene therapy developers a detailed framework for the conduct of umbrella trials, offering the potential for enhanced speed and efficiency in early-stage clinical trials.   In the umbrella trials envisioned under the draft guidance, two or more versions of a cellular or gene therapy product would be studied for one specific disease using just one trial design, shared infrastructure, a...
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    FDA addresses microbial contamination in non-sterile drugs

    The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to help manufacturers control microbiological contamination of their non-sterile drugs (NSDs). The guidance stems from FDA’s concerns over a high number of adverse events and recalls associated with contaminated products.   The agency reports receiving 197 adverse event reports from microbiological or fungal contamination of non-sterile products between 2014 and 2017. Of these, 32 were deeme...
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    Pharmaceutical industry signals support for FDA’s BsUFA III commitment letter

    Two major pharmaceutical industry groups have endorsed the US Food and Drug Administration’s (FDA’s) recent commitment letter under its Biosimilar User Fee Amendments (BsUFA III) program which will run from FY 2023 to 2027, calling it an “an important milestone.”   After months of negotiation with industry, FDA released the commitment letter for the third iteration of BsUFA III in mid-September (RELATED: BsUFA III commitment letter details FDA, industry goals for bio...
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    Should the US government share the Moderna COVID vaccine recipe?

    As much of the developing world struggles to gain access to COVID-19 vaccine doses, some legal experts say the key lies in having the US government share the step-by-step instructions for manufacturing and testing the Moderna mRNA vaccine with other manufacturers.   In a recent Health Affairs blog , Christopher J. Morten, Zain Rizvi, and Ameet Sarpatwari made the case that the US government, through its contract with Moderna, has both access to the details of how the ...
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    FDA issues draft guidance on electronic 510(k) submissions

    The US Food and Drug Administration (FDA) on Tuesday issued a draft guidance to assist sponsors in using an electronic template for submitting a premarket notification 510(k).   In the draft guidance , FDA said it will accept the electronic Submission Template and Resource (eSTAR) template for applications to the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER).    The guidance implements section 745(A)(...
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    Drugs for non-TB pulmonary disease see new FDA guidance

    A new draft guidance from the US Food and Drug Administration (FDA) lays out considerations for sponsors who are developing drugs to treat certain lung infections caused by a mycobacterium related to the organism that causes tuberculosis.   The draft, posted to the FDA website on Tuesday, guides developers of drugs to treat nontuberculous mycobacterial pulmonary disease caused by Mycobacterium avium complex (MAC). It follows an April 2019 public workshop held by FD...
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    ISPE: Global regulators discuss GMP deficiencies, data integrity, real-world evidence

    The COVID-19 public health emergency has prompted regulators to take a different approach to uncovering data integrity violations in virtual inspections compared to onsite inspections, said an official with Australia’s Therapeutic Goods Administration (TGA). The official also provided an update on the status of the EU’s good manufacturing practice (GMP) guide Annex 1, which addresses the manufacture of sterile medicinal products, at a 24 September panel discussion sponsore...
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    Pharmaceutical trading partners lagging in exchanging electronic product information

    Pharmaceutical trading partners are behind the curve in exchanging electronic product information with each other under a mandate established by the Drug Supply Chain Security Act (DSCSA) that requires these exchanges go live by 27 November 2023.   Roughly half of manufacturers and distributors say they are currently exchanging EPICIS Electronic Product Code Information Services (EPICIS) data with each other, while these data are not being exchanged at all between dist...
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    Three foreign OTC firms slapped with warning letters for GMP testing violations

    Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...
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    FDA OKs new pathology AI software, launches AI-enabled device database

    The US Food and Drug Administration (FDA) has authorized software designed to help pathologists detect prostate cancer in digitally scanned slides from prostate biopsies. Separately, the agency announced Wednesday that it has made available a list of devices that use artificial intelligence and machine learning.   The newly authorized software, called Paige Prostate, is the first artificial intelligence (AI) tool okayed by FDA for in vitro diagnostic use for prostate...
  • RoundupsRoundups

    FDA Approvals Roundup: Exkivity, Tivdak, Opzelura

    A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).   New approvals Exkivity okayed as oral therapy for advanced NSCLC with certain mutations Takeda’s Exkivity (mobocertinib capsules) has been granted accelerated approval as an oral treatment for treating locally advanced or metastatic non-small cell lung cancer (NSCLC) in adults with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as d...
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    FDA guidance covers frequently asked CMC questions for generic drugs

    The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday issued a draft guidance that provides generic drug applicants with answers to commonly asked questions in the drug quality area. The new guidance is designed to provide an immediate response to such questions to reduce the number of controlled correspondence on identical topics.   The guidance, which is in a question-and-answer format, covers FDA’s policies on quality...