Drugs

ORA Issues 40% More Drug Warning Letters in FY 2018

FDA’s Office of Regulatory Affairs stepped up its Warning Letter issuance to pharmaceutical firms in fiscal year 2018 and issued 40% more letters, according to statistics (stats begin pg. 39) from FDA assistant commissioner for medical products and tobacco operations Ellen Morrison. There were 94 pharmaceutical-related Warning Letters issued in 2018 — 75 to international firms and 19 to domestic manufacturers. In 2017, 67 Warning Letters were issued (52 international and 15 domestic).

According to the statistics, the top drug inspection citations in FY 2018 were:

211.84(d)(1) and (2) — Components tested for identity and conformity with specifications.

211.100(a) — Validated production and process controls.

211.192 — Complaint investigations.

211.165(a) — Failure to test finished products.

211.22(a) — Responsibilities of quality unit.

211.166(a) — Inadequate stability testing.

211.194(a) — Laboratory records include complete data.

211.22(a) and (d) — Responsibilities of quality unit; written procedures.

211.67(b) — Written procedures for equipment cleaning and maintenance.

211.165(a) and (b) — Failure to test finished products, including for microorganisms.

211.137(a) — Expiration dating determined by appropriate stability testing.

211.42(c) — Separate areas to prevent contamination or mix-ups.

211.22(d) — Written procedures for responsibilities of quality unit

211.160(b) — Lack of established lab controls

In 2017, the top drug inspection citations were:

211.192 — Complaint investigations.

211.100(a) — Validated production and process controls.

211.113(b) — Control of microbiological contamination (sterile).

211.165(a) — Failure to test finished products.

211.160(b) — Lack of established lab controls.

211.84(d)(1) and (2) — Components tested for identity and conformity with specifications.

211.22(d) — Written procedures for responsibilities of quality unit.

211.67(a) — Equipment cleaning and maintenance.

211.22(a) — Responsibilities of quality unit.

211.194(a) — Laboratory records include complete data

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome