Drugs

FDA Releases 27-Page Mylan FDA-483

FDA has released the 27-page Form FDA-483 with six observations from a 5/4-5/15 inspection at the Mylan Laboratories drug manufacturing facility in Maharashtra, India. The inspection observations were:

failure to fully follow the responsibilities and procedures applicable to the quality control unit;
failure to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch had been already distributed;
equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality, or purity of the drug product;
failure to follow the written stability testing program; and
failure to submit a Field Alert Report within three days of receiving information concerning a failure of one or more distributed batches of a drug to meet the specifications established in the application.

Bill to Speed Rare Disease Trials

Bipartisan legislation intended to accelerate the development of rare disease treatments by making clinical trials faster, cheaper, and more accessible to patients was to be introduced in the House on 10/22 by Reps. Jake Auchincloss (D-MA) and Morgan Griffith (R-VA). CNBC Cures reports that the Faster Clinical

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

The Partnership for Safe Medicines (PSM) has filed a citizen petition urging FDA to ban compounding of unapproved peptides and to disregard the advisory committee vote that recommended allowing them. The advocacy group contends the committee was constituted in violation of the Federal Advisory Committee Act and the Ethics in

Support For and Ideas to Change GDUFA 4

The Association for Accessible Medicines (AAM), which represents America’s generic and biosimilar drug sector, says it “strongly supports” the proposed GDUFA 4 commitment letter outlining the agreement negotiated between FDA and the industry. “GDUFA has played an essential role in strengthening the generic drug review process, helping to ensure

SARMS Pharm Sentenced in Unapproved Drug Case

The U.S. Justice Department says Jeffrey McIndoo (Phoenix, AZ) and his company, JeffMac Investments LLC doing business as SARMS Pharm LLC , were sentenced following prior guilty pleas over the alleged illicit sale of potentially dangerous chemical substances known as selective androgen receptor modulators (SARMs). SARMS mimic the effects of

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Bill to Speed Rare Disease Trials

Advocacy Group Files Petition Urging FDA to Block Peptide Compounding

Support For and Ideas to Change GDUFA 4

SARMS Pharm Sentenced in Unapproved Drug Case