Category Archive: 505(b)(2)

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Happy multi-generation family holding Thanksgiving turkey together at dining table.

Hope at This Time of Giving Thanks

By | November 26, 2019 | 505(b)(2), Abuse deterrent, Accelerated Approval, Advertising, Analytical Methods, ANDAs, Approvals, Bioanalytical, Bioequivalence, Biologics, Biosimilars, BLA, Brand Name Drugs, Bulk Drugs List, CBER, CDER, Chemistry, Clinical, CMC, Combination Products, Complex Generics, Compliance, Compounders, Compounding, Controlled correspondence, CVM, Data Integrity, DEA, Device, Dietary Supplements, Drug Pricing, Drug Shortages, eCTD, Emerging Technology, Enforcement, Exclusivity, FDA, FDA, First Generics, Foods, GDUFA Fees, Generics, Guidance, Homeopathic Drugs, ICH, Imports, International, Label Changes, Labeling, Laboratories, Manufacturing, Medical Devices, NDA, New Drugs, OGD, Opioids, OTC, Petitions, PMA, Post Approval, projectsnowflake, Receipts, Regulatory Affairs, Safety, Science & Technology, Shortages, Training, Uncategorized, User Fees, Validation | 3 |

Just look around, watch the television, read the newspaper, and what do you see?  Seems like very few reasons to be thankful.  School and workplace shootings, the political scene is as nasty as I ever remember in my 70 years on earth.  Climate change is threatening the future of our children, and the environmental controls have been set back 50 years as the oceans continue to rise,

Petition Form

Revised 505(q) Petition Guidance Published

By | September 18, 2019 | 505(b)(2), ANDAs, BLA, FDA, Generics, Regulatory Affairs | 1 |

This guidance (here) finalizes the draft guidance for industry entitled “Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act” issued in October 2018 and supersedes the Guidance by the same name issued in November 2014.  The guidance document revision is based on comments that were submitted to the Agency after the original draft was introduced in 2018.